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You searched for: Subject term Food and Drug Administration Remove constraint Subject term: Food and Drug Administration Subject term drugs Remove constraint Subject term: drugs
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1. An Overview of Hepatocellular Carcinoma with Emphasis on Dietary Products and Herbal Remedies

Author:
Deepa S. Mandlik; Satish K. Mandlik
Source:
Nutrition and cancer 2022 v.74 no.5 pp. 1549-1567
ISSN:
1532-7914
Subject:
Food and Drug Administration; cancer therapy; chemical constituents of plants; drugs; etiology; hepatoma; nutrition; toxicity
Abstract:
... The most common principal malignant tumor that accounts for ∼80% of cases of liver cancer across the world is hepatocellular carcinoma (HCC). It is a multifacetedillness that is caused by several risk factors and often progresses in the context of underlying cirrhosis. It is tremendously difficult and essential for the screening of novel therapeutic medications to establish HCC preclinical models ...
DOI:
10.1080/01635581.2021.1965630

2. A simple, rapid, and robust “on‐the‐go” identity testing of biotherapeutics using FTIR spectroscopy

Author:
Mohammad A. Afzal; Purva P. Bhojane; Anurag S. Rathore
Source:
Electrophoresis 2021 v.42 no.16 pp. 1655-1664
ISSN:
0173-0835
Subject:
Food and Drug Administration; Fourier transform infrared spectroscopy; drugs; electrophoresis; labor
Abstract:
... The stunning rise of biotherapeutics as successful treatments of complex and hard‐to‐treat diseases, in particular cancer, has necessitated the development of a rapid analytical method capable of differentiating these otherwise significantly similar antibody‐based products. The existing methods for product identification pose significant drawbacks in terms of the consumption of time and labor. Her ...
DOI:
10.1002/elps.202100045

3. Challenges and opportunities in the development of complex generic long-acting injectable drug products

Author:
Matthew N. O'Brien; Wenlei Jiang; Yan Wang; David M. Loffredo
Source:
Journal of controlled release 2021 v.336 pp. 144-158
ISSN:
0168-3659
Subject:
Food and Drug Administration; drugs; industry; landscapes; patient compliance; product development; therapeutics
Abstract:
... Long-acting injectable (LAI) drug products enable the controlled release of a drug over an extended duration of time to improve the therapeutic effect, safety profile, or administration of an injectable product. The development of generic [505(j)] and differentiated [505(b)(2)] LAI products helps to provide patients and healthcare providers with more treatment options and to reduce overall healthc ...
DOI:
10.1016/j.jconrel.2021.06.017

4. Enhancing the preservation of liposomes: The role of cryoprotectants, lipid formulations and freezing approaches

Author:
Francesca Susa; Giulia Bucca; Tania Limongi; Valentina Cauda; Roberto Pisano
Source:
Cryobiology 2021 v.98 pp. 46-56
ISSN:
0011-2240
Subject:
Food and Drug Administration; biocompatibility; cellobiose; compliance; cryobiology; cryoprotectants; drugs; freeze drying; glucose; ice; lactose; lipid bilayers; lipids; liquid nitrogen; mannitol; sucrose; surfactants; trehalose
Abstract:
... In the last decades, liposomes acquired a striking success in the biomedical field thanks to their biocompatibility and drug delivery ability. Many liposomal drug formulations have been already approved by the Food and Drug Administration (FDA) and used for the treatment of a wide range of pathologies with or without further engineering. Their clinical application requires strict compliance with h ...
DOI:
10.1016/j.cryobiol.2020.12.009

5. Greenness assessment of micellar spectrofluorometric approach for determination of Elagolix: application to dosage form, content uniformity and human plasma

Author:
Rasha M. Ahmed
Source:
Heliyon 2021 v.7 no.12 pp. e08521
ISSN:
2405-8440
Subject:
Food and Drug Administration; antagonists; dosage forms; drugs; endometriosis; fluorescence; humans; pain; quality control; sodium dodecyl sulfate
Abstract:
... Ecological, sensitive, fast and economic approaches are the main aspects in quality control of pharmaceutical products. Elagolix (ELG) is an orally non-peptidic GnRH antagonist, recently approved drug by Food and drug administration in 2018 for treatment of pain associated with endometriosis. A green, and sensitive method was developed and validated for determination of ELG based on micellar spect ...
DOI:
10.1016/j.heliyon.2021.e08521

6. Hypothiocyanite and Hypothiocyanite/Lactoferrin Mixture Exhibit Virucidal Activity In Vitro against SARS-CoV-2

Author:
Luca Cegolon; Mattia Mirandola; Claudio Salaris; Maria Vittoria Salvati; Giuseppe Mastrangelo; Cristiano Salata
Source:
Pathogens 2021 v.10 no.2 pp. -
ISSN:
2076-0817
Subject:
COVID-19 infection; Food and Drug Administration; Severe acute respiratory syndrome coronavirus 2; antiviral properties; drugs; innate immunity; lactoferrin
Abstract:
... SARS-CoV-2 replicates efficiently in the upper airways during the prodromal stage, resulting in environmental viral shedding from patients with active COVID-19 as well as from asymptomatic individuals. There is a need to find pharmacological interventions to mitigate the spread of COVID-19. Hypothiocyanite and lactoferrin are molecules of the innate immune system with a large spectrum cidal activi ...
DOI:
10.3390/pathogens10020233

7. Marine Power on Cancer: Drugs, Lead Compounds, and Mechanisms

Author:
Lichuan Wu; Ke Ye; Sheng Jiang; Guangbiao Zhou
Source:
Marine drugs 2021 v.19 no.9 pp. -
ISSN:
1660-3397
Subject:
Food and Drug Administration; antineoplastic activity; biosphere; breast neoplasms; drugs; lymphoma; metastasis; therapeutics
Abstract:
... Worldwide, 19.3 million new cancer cases and almost 10.0 million cancer deaths occur each year. Recently, much attention has been paid to the ocean, the largest biosphere of the earth that harbors a great many different organisms and natural products, to identify novel drugs and drug candidates to fight against malignant neoplasms. The marine compounds show potent anticancer activity in vitro and ...
DOI:
10.3390/md19090488

8. Non-invasive detection technologies of solid foreign matter and their applications to lyophilized pharmaceutical products: A review

Author:
Inès E. Achouri; Alan Rhoden; Sophie Hudon; Ryan Gosselin; Jean-Sébastien Simard; Nicolas Abatzoglou
Source:
Talanta 2021 v.224 pp. 121885
ISSN:
0039-9140
Subject:
Food and Drug Administration; X-radiation; cakes; detection; drugs; freeze drying; good manufacturing practices; image analysis; manufacturing; materials; particles; particulates; pharmaceutical industry; reliability; sampling; spectroscopy; ultrasonics
Abstract:
... Good Manufacturing Practice Regulations, under the Food and Drug Administration (FDA), stipulate that all pharmaceutical products must be free of any contaminants, including, namely, any foreign solid objects. Lyophilization is a common manufacturing method that consists of several steps where foreign materials may enter the product. The presence of unintended particles in freeze drying, which wil ...
DOI:
10.1016/j.talanta.2020.121885

9. Not only in silico drug discovery: Molecular modeling towards in silico drug delivery formulations

Author:
Tommaso Casalini
Source:
Journal of controlled release 2021 v.332 pp. 390-417
ISSN:
0168-3659
Subject:
Food and Drug Administration; HIV integrase; computer simulation; drugs; integrase inhibitors; ligands; molecular dynamics; nanomedicine
Abstract:
... The use of methods at molecular scale for the discovery of new potential active ligands, as well as previously unknown binding sites for target proteins, is now an established reality. Literature offers many successful stories of active compounds developed starting from insights obtained in silico and approved by Food and Drug Administration (FDA). One of the most famous examples is raltegravir, a ...
DOI:
10.1016/j.jconrel.2021.03.005

10. Photoacoustic method for real-time assessment of salt content in aqueous solutions

Author:
João Henriques; Fábio A. Schaberle; Carlos Serpa; Alberto A.C.C. Pais; Catarina Cardoso; Carla Vitorino
Source:
Talanta 2021 v.222 pp. 121497
ISSN:
0039-9140
Subject:
Food and Drug Administration; analytical methods; aqueous solutions; detection limit; detectors; drugs; manufacturing; process control; salt content; sodium chloride
Abstract:
... In 2004, the Food and Drug Administration established the foundations for the application of process analytical technologies (PAT) in real-time control of the drug manufacturing process, where progress has been essentially directed to solid formulations. In order to enlarge the application of PAT principles to injectable drug products, the development of appropriate manufacturing process control t ...
DOI:
10.1016/j.talanta.2020.121497

11. The application of Raman spectroscopy for monitoring product quality attributes in perfusion cell culture

Author:
Zimin Liu; Zhijun Zhang; Yongjun Qin; Gong Chen; Jun Hu; Qing Wang; Weichang Zhou
Source:
Biochemical engineering journal 2021 v.173 pp. 108064
ISSN:
1369-703X
Subject:
Food and Drug Administration; Raman spectroscopy; bioreactors; cell culture; drugs; gel chromatography; least squares; mammals; mannose; microchip technology; model validation; pH; prediction; product quality; quality control
Abstract:
... In-situ Raman spectroscopy provides enhanced capabilities to monitor and control the mammalian cell culture process in real-time, which conforms to the concepts Process Analytical Technology (PAT) and Quality by Design (QbD) raised by U.S. Food and Drug Administration (FDA), and help us to overcome the challenges encountered in the Pharmaceutical R&D. Product quality control was addressed in FDA’s ...
DOI:
10.1016/j.bej.2021.108064

12. Variable accuracy, precision, and consistency of compounded famciclovir formulated for management of feline herpesvirus‐1 in cats

Author:
Louise M. O'Leary; Rachel A. Allbaugh; Dwayne E. Schrunk; Thomas E. Olsen; Lionel Sebbag
Source:
Veterinary ophthalmology 2021 v.24 no.6 pp. 627-638
ISSN:
1463-5216
Subject:
Felid alphaherpesvirus 1; Food and Drug Administration; drugs; high performance liquid chromatography; ophthalmology; reference standards
Abstract:
... OBJECTIVE: To evaluate compounded famciclovir suspensions for accuracy, precision, and consistency in drug content. PROCEDURES: Two compounded famciclovir concentrations were evaluated (250 and 400 mg/mL, 30 preparations total from nine 503A compounding pharmacies) with U.S. Food and Drug Administration (FDA)‐approved famciclovir tablets as control. Drug quantification via high‐performance liquid ...
DOI:
10.1111/vop.12910

13. A novel galactose electrochemical biosensor intended for point-of-care measurement of quantitative liver function using galactose single-point test

Author:
Kuo-Ming Yu; Ping Yang; Tien-Yu Huang; Thomas Yen-Shih Shen; Johnson Yiu-Nam Lau; Oliver Yoa-Pu Hu
Source:
Analytical and bioanalytical chemistry 2022 v.414 no.14 pp. 4067-4077
ISSN:
1618-2642
Subject:
Food and Drug Administration; analytical chemistry; biosensors; blood; colorimetry; cost effectiveness; disease control; drugs; electrochemistry; galactose; galactosemia; hematocrit; hepatectomy; liver; liver diseases; liver function; pandemic; point-of-care systems; toxicity
Abstract:
... Liver disease has emerged as a healthcare burden because of high hospitalization rates attributed both to steatohepatitis and to severe hepatic toxicity associated with changes of drug exposure. Early detection of hepatic insufficiency is critical to preventing long-term liver damage. The galactose single-point test is recommended by the US FDA as a sensitive means to quantify liver function, yet ...
DOI:
10.1007/s00216-022-04051-1

14. An integrated chemo-informatics and in vitro experimental approach repurposes acarbose as a post-ischemic neuro-protectant

Author:
Jyotirekha Das; Fayaz Shaik Mahammad; Rajanikant Golgodu Krishnamurthy
Source:
3 Biotech 2022 v.12 no.3 pp. 71
ISSN:
2190-572X
Subject:
Food and Drug Administration; acarbose; apoptosis; cell proliferation; cell viability; databases; drug therapy; drugs; fluorescence; gene expression; inflammation; ischemia; low calorie diet; mitochondria; molecular dynamics; necrosis; neurites; neuroprotective effect; protein kinases; protein-protein interactions; stroke
Abstract:
... The increasing prevalence of ischemic stroke combined with limited therapeutic options highlights the compelling need for continued research into the development of future neuro-therapeutics. Death-Associated Protein Kinase 1 (DAPK1) and p53 protein–protein interaction serve as a signaling point for the convergence of apoptosis and necrosis in cerebral ischemia. In this study, we used an integrate ...
DOI:
10.1007/s13205-022-03130-5

15. Deciphering the Interactions of SARS-CoV-2 Proteins with Human Ion Channels Using Machine-Learning-Based Methods

Author:
Nupur S. Munjal; Dikscha Sapra; K. T. Shreya Parthasarathi; Abhishek Goyal; Akhilesh Pandey; Manidipa Banerjee; Jyoti Sharma
Source:
Pathogens 2022 v.11 no.2 pp. -
ISSN:
2076-0817
Subject:
COVID-19 infection; Food and Drug Administration; Severe acute respiratory syndrome coronavirus 2; algorithms; calcium; drugs; economic crises; humans; pathogenesis; pathogenicity; taste; therapeutics
Abstract:
... Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is accountable for the protracted COVID-19 pandemic. Its high transmission rate and pathogenicity led to health emergencies and economic crisis. Recent studies pertaining to the understanding of the molecular pathogenesis of SARS-CoV-2 infection exhibited the indispensable role of ion channels in viral infection inside the host. Moreover ...
DOI:
10.3390/pathogens11020259

16. Development and validation of a new liquid chromatography-tandem mass spectrometry assay for the simultaneous quantification of afatinib, dacomitinib, osimertinib, and the active metabolites of osimertinib in human serum

Author:
Emi Ishikawa; Yuta Yokoyama; Haruna Chishima; Ouki Kuniyoshi; Itaru Sato; Naoki Nakaya; Hideo Nakajima; Motonori Kimura; Jun Hakamata; Naoya Suehiro; Hideo Nakada; Shinnosuke Ikemura; Aya Jibiki; Hitoshi Kawazoe; Hiroshi Muramatsu; Sayo Suzuki; Tomonori Nakamura
Source:
Journal of chromatography 2022 v.1199 pp. 123245
ISSN:
1570-0232
Subject:
Food and Drug Administration; blood serum; chemical species; drugs; epidermal growth factor; humans; liquid chromatography; lung neoplasms; metabolites; tandem mass spectrometry; therapeutics
Abstract:
... Reports on the therapeutic drug monitoring (TDM) of second- and third-generation epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) in non-small cell lung cancer patients are limited and are required to improve the safety of EGFR-TKI therapy. Some EGFR-TKIs have active metabolites with similar or higher potency compared with the parent compounds; thus, monitoring the parent co ...
DOI:
10.1016/j.jchromb.2022.123245

17. Development of UPLC-MS/MS method and its pharmacokinetic application for estimation of sertraline in rat plasma

Author:
Mohammad Akhlaquer Rahman
Source:
MethodsX 2022 v.9 pp. 101750
ISSN:
2215-0161
Subject:
Food and Drug Administration; chemical species; cost effectiveness; drugs; guidelines; oral administration; pharmacokinetics; rats; toxicity
Abstract:
... The current research aims to develop a rapid, sensitive and robust UPLC-MS/MS method for quantitative estimation of sertraline in rat plasma following oral administration of lipid-based formulation. Different types of isocratic systems were tried for optimization of mobile phase to attain good resolution and appropriate retention time. The multiple reaction monitoring transitions of m/z 306.3 → 15 ...
DOI:
10.1016/j.mex.2022.101750

18. Highly sensitive simultaneous quantification of indoxyl sulfate and 3‐carboxy‐4‐methyl‐5‐propyl‐2‐furanpropanoic acid in human plasma using ultra‐high‐performance liquid chromatography coupled with tandem mass spectrometry

Author:
Ayako Oda; Yosuke Suzuki; Banri Sato; Haruki Sato; Ryota Tanaka; Hiroyuki Ono; Tadasuke Ando; Toshitaka Shin; Hiromitsu Mimata; Hiroki Itoh; Keiko Ohno
Source:
Journal of separation science 2022 v.45 no.10 pp. 1672-1682
ISSN:
1615-9306
Subject:
Food and Drug Administration; cytochrome P-450; drugs; enzymes; humans; polypeptides; renal failure; separation; solid phase extraction; sulfates; tandem mass spectrometry; ultra-performance liquid chromatography
Abstract:
... Indoxyl sulfate and 3‐carboxy‐4‐methyl‐5‐propyl‐2‐furanpropanoic acid are uremic toxins that accumulate in renal failure and have been reported to decrease the activities of the drug‐metabolizing enzyme cytochrome P450 3A and the drug transporter organic anion transporting polypeptides 1B, respectively. In this study, we established and validated an assay for simultaneous quantification of indoxyl ...
DOI:
10.1002/jssc.202100950

19. In vivo and in vitro studies of antisense oligonucleotides – a review

Author:
Anna Kilanowska; Sylwia Studzińska
Source:
RSC advances 2020 v.10 no.57 pp. 34501-34516
ISSN:
2046-2069
Subject:
Food and Drug Administration; drugs; enzymes; genes; humans; liver microsomes; mechanism of action; oligonucleotides; pharmacokinetics; therapeutics
Abstract:
... The potential of antisense oligonucleotides in gene silencing was discovered over 40 years ago, which resulted in the growing interest in their chemistry, mechanism of action, and metabolic pathways. This review summarizes the selected mechanisms of antisense drug action, as well as therapeutics which are to date approved by the Food and Drug Administration and European Medicines Agency. Moreover, ...
DOI:
10.1039/d0ra04978f

20. Intraarticularly injectable silk hydrogel microspheres with enhanced mechanical and structural stability to attenuate osteoarthritis

Author:
Tao Wang; Yuqi Li; Jian Liu; Yan Fang; Wenjun Guo; Yu Liu; Xiangyu Li; Gang Li; Xiuli Wang; Zhaozhu Zheng; Xiaoqin Wang; David L. Kaplan
Source:
Biomaterials 2022 v.286 pp. 121611
ISSN:
0142-9612
Subject:
Food and Drug Administration; analgesia; aqueous solutions; biocompatibility; biocompatible materials; biodegradation; biolubricants; cartilage; crosslinking; drugs; emulsifying; fibroins; formic acid; hyaluronic acid; hydrogels; immunohistochemistry; lithium; microparticles; oils; osteoarthritis; pain; silk; solubilization; strength (mechanics)
Abstract:
... A silk fibroin (silk) hydrogel was prepared by using diglycidyl ether (BDDE), a chemical crosslinker commonly used to generate Food and Drug Administration (FDA)-approved hyaluronic acid (HA) medical products. The silk/BDDE hydrogels exhibited high elasticity (compressive modulus of 166 ± 15.0 kPa), anti-fatigue properties, and stable structure and mechanical strength in aqueous solution. Chemical ...
DOI:
10.1016/j.biomaterials.2022.121611

21. Nanocarrier mediated drug delivery as an impeccable therapeutic approach against Alzheimer’s disease

Author:
Rajeev Taliyan; Violina Kakoty; K.C. Sarathlal; Sanskruti Santosh Kharavtekar; Chandrashekar R. Karennanavar; Yogendra Kumar Choudhary; Gautam Singhvi; Yassine Riadi; Sunil Kumar Dubey; Prashant Kesharwani
Source:
Journal of controlled release 2022 v.343 pp. 528-550
ISSN:
0168-3659
Subject:
Food and Drug Administration; acetylcholinesterase; antagonists; blood-brain barrier; brain; drug therapy; drugs; elderly; memory; nanocarriers; nanomedicine; neurodegenerative diseases; neuroprotective effect; xenobiotics
Abstract:
... For the past several years, dementia, is one of the predominantly observed groups of symptoms in a geriatric population. Alzheimer’s disease (AD) is a progressive memory related neurodegenerative disease, for which the current Food and drug administration approved therapeutics are only meant for a symptomatic management rather than targeting the root cause of AD. These therapeutics belong to two c ...
DOI:
10.1016/j.jconrel.2022.01.044

22. Predicting the Activities of Drug Excipients on Biological Targets using One-Shot Learning

Author:
Xuenan Mi; Diwakar Shukla
Source:
Journal of physical chemistry 2022 v.126 no.7 pp. 1492-1503
ISSN:
1520-5207
Subject:
Food and Drug Administration; drugs; ligands; phosphotransferases (kinases); physical chemistry
Abstract:
... Excipients are major components of drugs and are used to improve drug attributes such as stability and appearance. Excipients approved by the U.S. Food and Drug Administration (FDA) are regarded as safe for humans in allowed concentrations, but their potential interactions with drug targets have not been investigated systematically, which might influence a drug’s efficacy. Deep learning models hav ...
DOI:
10.1021/acs.jpcb.1c10574

23. Preliminary Pilot Study of Itraconazole After a Single Oral Dose of a Veterinary Formulation Solution in African Penguins (Spheniscus demersus)

Author:
Selina M. Zalesak; Carlos R. Sanchez; Ashley A. Pich; Mark G. Papich
Source:
Journal of avian medicine and surgery 2020 v.34 no.1 pp. 52-56
ISSN:
1082-6742
Subject:
Food and Drug Administration; Spheniscus demersus; aspergillosis; bird diseases; blood sampling; cats; drugs; high performance liquid chromatography; humans; itraconazole; morbidity; mortality; oral administration; penguins; sample size
Abstract:
... Aspergillosis is a common cause of morbidity and mortality in captive penguins. Itraconazole, an antifungal drug, is commonly used to treat aspergillosis infections in avian species; however, commercially available human formulations are costly, and studies have shown the effectiveness of compounded formulations to be unreliable. The US Food and Drug Administration (FDA) recently approved a veteri ...
DOI:
10.1647/1082-6742-34.1.52

24. Progress in the drug encapsulation of poly(lactic-co-glycolic acid) and folate-decorated poly(ethylene glycol)–poly(lactic-co-glycolic acid) conjugates for selective cancer treatment

Author:
Jagan Mohan Dodda; Tomáš Remiš; Sadiku Rotimi; Yi-Cheun Yeh
Source:
Journal of materials chemistry B 2022 v.10 no.22 pp. 4127-4141
ISSN:
2050-7518
Subject:
Food and Drug Administration; bioactive properties; biocompatibility; breasts; cancer therapy; death; drugs; encapsulation; lungs
Abstract:
... Poly(lactic-co-glycolic acid) (PLGA) is a US Food and Drug Administration (FDA)-approved polymer used in humans in the forms of resorbable sutures, drug carriers, and bone regeneration materials. Recently, PLGA-based conjugates have been extensively investigated for cancer, which is the second leading cause of death globally. This article presents an account of the literature on PLGA-based conjuga ...
DOI:
10.1039/d2tb00469k

25. Pyridine: the scaffolds with significant clinical diversity

Author:
Sourav De; Ashok Kumar S K; Suraj Kumar Shah; Sabnaz Kazi; Nandan Sarkar; Subhasis Banerjee; Sanjay Dey
Source:
RSC advances 2022 v.12 no.24 pp. 15385-15406
ISSN:
2046-2069
Subject:
Food and Drug Administration; drugs; moieties; pyridines
Abstract:
... The nitrogen-bearing heterocycle pyridine in its several analogous forms occupies an important position as a precious source of clinically useful agents in the field of medicinal chemistry research. This privileged scaffold has been consistently incorporated in a diverse range of drug candidates approved by the FDA (Food and Drug Administration). This moiety has attracted increasing attention from ...
DOI:
10.1039/d2ra01571d

26. Recent progress in alginate-based carriers for ocular targeting of therapeutics

Author:
Sandip Karmakar; Sreejan Manna; Sourav Kabiraj; Sougata Jana
Source:
Food hydrocolloids for health 2022 v.2 pp. 100071
ISSN:
2667-0259
Subject:
Food and Drug Administration; bioadhesives; bioavailability; biodegradability; brain; drugs; gelation; humans; hydrocolloids; sodium alginate; therapeutics; thickeners
Abstract:
... Eye is one of the susceptible organs of the human body which is associated with several internal organs including the brain. Due to the protective mechanisms of body and ocular barrier properties, the area of ocular drug delivery presents a challenge to pharmaceutical researchers. Alginate is a naturally occurring polysaccharide obtained from marine brown seaweeds and bacterial sources. According ...
DOI:
10.1016/j.fhfh.2022.100071

27. Simple and fast UPLC-MS method for quantifying the anti-inflammatory candidate 5′-methoxynobiletin in rat plasma: Validation and application in a preliminary pharmacokinetic study

Author:
Larissa Gabriela Faqueti; Layzon Antonio Lemos da Silva; Gabriela Salim Gomes Moreira; Luciana Aparecida Honorato; Adair Roberto Soares dos Santos; Teresa Dalla Costa; Maique Weber Biavatti
Source:
Journal of chromatography 2020 v.1158 pp. 122387
ISSN:
1570-0232
Subject:
Food and Drug Administration; acetonitrile; chrysin; drugs; formic acid; intravenous injection; pharmacokinetics; quality control; rats; standard deviation; tandem mass spectrometry
Abstract:
... This study presents the development and validation of a fast and simple bioanalytical ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS) method intended for quantifying the anti-inflammatory candidate 5′-methoxynobiletin (5′-MeONB) in rat plasma. Standard of 5′-MeONB was purified from A. conyzoides extract by using preparative HPLC. After a pretreatment of plasma samples wi ...
DOI:
10.1016/j.jchromb.2020.122387

28. Translation of aptamers toward clinical diagnosis and commercialization

Author:
Shan Liu; Yixin Xu; Xin Jiang; Hong Tan; Binwu Ying
Source:
Biosensors & bioelectronics 2022 v.208 pp. 114168
ISSN:
0956-5663
Subject:
Food and Drug Administration; biosensors; commercialization; diagnostic techniques; drugs; immunogenicity; manufacturing; oligonucleotides
Abstract:
... The dominance of antibodies in diagnostics has gradually changed following the discovery of aptamers in the early 1990s. Aptamers offer inherent advantages over traditional antibodies, including higher specificity, higher affinity, smaller size, greater stability, ease of manufacture, and low immunogenicity, rendering them the best candidates for point-of-care testing (POCT). In the past 20 years, ...
DOI:
10.1016/j.bios.2022.114168

29. Aggregation and analysis of secondary pharmacology data from investigational new drug submissions at the US Food and Drug Administration

Author:
Andrew Dodson; Kevin Mi; Daniel P. Russo; Christina Scott; Muriel Saulnier; Kevin Snyder; Rebecca Racz
Source:
Journal of pharmacological and toxicological methods 2021 v.111 pp. 107098
ISSN:
1056-8719
Subject:
Food and Drug Administration; NAD(P)H dehydrogenase (quinone); adenosine; benzodiazepines; cost effectiveness; drugs; pharmaceutical industry; pharmacology; toxicology
Abstract:
... Secondary pharmacology studies are utilized by the pharmaceutical industry as a cost-efficient tool to identify potential safety liabilities of drugs before entering Phase 1 clinical trials. These studies are recommended by the Food and Drug Administration (FDA) as a part of the Investigational New Drug (IND) application. However, despite the utility of these assays, there is little guidance on wh ...
DOI:
10.1016/j.vascn.2021.107098

30. Allergenic components, biocides, and analysis techniques of some essential oils used in food products

Author:
Aykut Türkmenoğlu; Dilek Özmen
Source:
Journal of food science 2021 v.86 no.6 pp. 2225-2241
ISSN:
0022-1147
Subject:
Food and Drug Administration; adverse effects; allergenicity; antioxidants; biocides; chlorinated hydrocarbons; drugs; essential oils; food preservation; humans; hypersensitivity; kidney diseases; liquid chromatography; mucosa; nausea; necrosis; prediction; skin irritation; transportation; world markets
Abstract:
... Nowadays, almost 300 essential oils (EOs) are commonly traded in the world market, with a prediction to be worth over $14 billion in 2024. EOs are natural preservatives for food products in order to reduce the activity of pathogenic microorganisms, therefore their use as an antioxidant or a preservative in foods has been encouraged. They are not only considered as antimicrobial or flavoring agents ...
DOI:
10.1111/1750-3841.15753

31. Bacterial vaginosis: An insight into the prevalence, alternative treatments regimen and it's associated resistance patterns

Author:
Ayesha Javed; Fahed Parvaiz; Sobia Manzoor
Source:
Microbial pathogenesis 2019 v.127 pp. 21-30
ISSN:
0882-4010
Subject:
Papillomaviridae; funding; immunosuppression; Neisseria gonorrhoeae; guidelines; bacteriophages; lactic acid; Food and Drug Administration; drugs; parturition; clindamycin; flora; patients; sexually transmitted diseases; pathogenesis; bacterial infections; females; geographical distribution; metronidazole; Lactobacillus; Human immunodeficiency virus; clinical trials; phage therapy; adverse effects; virulent strains; activated carbon; vagina; Human alphaherpesvirus 1; antibiotic resistance; biofilm; thermoplastics; secondary infection; deficiency diseases; disease transmission; probiotics; pH; polyurethanes
Abstract:
... Bacterial Vaginosis (BV) is a complex polymicrobial infection of vagina that shifts the paradigms of vaginal flora from lactobacilli to opportunistic pathogens. BV is catagorized by greyish white discharge, pH greater than 4.5. It results in the preterm labor, abortion, pelvic inflammatory disorders, post cesarean infections. BV is associated with Sexually Transmitted Diseases (STDs) or immune def ...
DOI:
10.1016/j.micpath.2018.11.046

32. Complex sameness: Separation of mixed poly(lactide-co-glycolide)s based on the lactide:glycolide ratio

Author:
Sarah Skidmore; Justin Hadar; John Garner; Haesun Park; Kinam Park; Yan Wang; Xiaohui (Jeff) Jiang
Source:
Journal of controlled release 2019 v.300 pp. 174-184
ISSN:
0168-3659
Subject:
Food and Drug Administration; carbon; drugs; engineering; gel chromatography; markets; molecular weight; nuclear magnetic resonance spectroscopy; polystyrenes; quality control; solubility; solvents; stable isotopes
Abstract:
... Poly (lactide-co-glycolide) (PLGA) has been used for making injectable, long-acting depot formulations for the last three decades. An in depth understanding of PLGA polymers is critical for development of depot formulations as their properties control drug release kinetics. To date, about 20 PLGA-based formulations have been approved by the U.S. Food and Drug Administration (FDA) through new drug ...
DOI:
10.1016/j.jconrel.2019.03.002

33. Crystal structure of CD38 in complex with daratumumab, a first-in-class anti-CD38 antibody drug for treating multiple myeloma

Author:
Hyun Tae Lee; Yujin Kim; Ui Beom Park; Tae Jun Jeong; Sang Hyung Lee; Yong-Seok Heo
Source:
Biochemical and biophysical research communications 2021 v.536 pp. 26-31
ISSN:
0006-291X
Subject:
Food and Drug Administration; active sites; antibodies; bone marrow; crystal structure; drugs; epitopes; glycoproteins; mechanism of action; myeloma; research
Abstract:
... Multiple myeloma is a blood cancer characterized by the plasma cell malignancy in the bone marrow, resulting in the destruction of bone tissue. Recently, the US FDA approved two antibody drugs for the treatment of multiple myeloma, daratumumab and isatuximab, targeting CD38, a type II transmembrane glycoprotein highly expressed in plasma cells and multiple myeloma cells. Here, we report the crysta ...
DOI:
10.1016/j.bbrc.2020.12.048

34. Desorption/Ionization-MS Methods for Drug Quantification in Biological Matrices and Their Validation Following Regulatory Guidance

Author:
Margaux Fresnais; Jürgen Burhenne; Walter E. Haefeli; Rémi Longuespée
Source:
Analytical chemistry 2021 v.93 no.19 pp. 7152-7163
ISSN:
1520-6882
Subject:
Food and Drug Administration; analytical chemistry; desorption; drugs; ionization; ligands; mass spectrometry; pharmacodynamics; pharmacokinetics
Abstract:
... Desorption/ionization (DI) methods play an important role among the panel of mass spectrometric (MS) approaches for the rapid and sensitive quantification of drugs from the surface of solid samples. The possibility to implement these approaches for pharmacokinetic/pharmacodynamic investigations in early phase clinical trials depends on the ability to validate quantification assays according to reg ...
DOI:
10.1021/acs.analchem.1c00647

35. Development and Standardization of Moringa oleifera Leaves as a Natural Dietary Supplement

Author:
Muhammad Azhar Ali; Yus Aniza Yusof; Nyuk Ling Chin; M. N. Ibrahim; Sadaf Muneer
Source:
Journal of dietary supplements 2019 v.16 no.1 pp. 66-85
ISSN:
1939-022X
Subject:
Food and Drug Administration; Moringa oleifera; bitterness; computer software; dietary supplements; drugs; hardness; tensile strength; toxicity
Abstract:
... Moringa oleifera leaves were selected as a model due to their hundreds of health benefits. On the other hand, the powder of these leaves has exhibited poor flowability, low tensile strength, bitter taste, poor dissolution rate, and lack of information regarding dosage. These are the common hurdles and limitations in the adaptation of herbal-based medications. Therefore, a comprehensive study was p ...
DOI:
10.1080/19390211.2018.1429517

36. Development of Protein- and Peptide-Based HIV Entry Inhibitors Targeting gp120 or gp41

Author:
Jing Pu; Qian Wang; Wei Xu; Lu Lu; Shibo Jiang
Source:
Viruses 2019 v.11 no.8 pp. -
ISSN:
1999-4915
Subject:
Food and Drug Administration; HIV infections; Human immunodeficiency virus 1; antiretroviral agents; clinical trials; drugs; mechanism of action; morbidity; mortality; multiple drug resistance; patients
Abstract:
... Application of highly active antiretroviral drugs (ARDs) effectively reduces morbidity and mortality in HIV-infected individuals. However, the emergence of multiple drug-resistant strains has led to the increased failure of ARDs, thus calling for the development of anti-HIV drugs with targets or mechanisms of action different from those of the current ARDs. The first peptide-based HIV entry inhibi ...
DOI:
10.3390/v11080705
PubMed:
31374953
PubMed Central:
PMC6722851

37. Elastographic liver evaluation of Katukyadi churna in the management of Non-Alcoholic Steatohepatitis (NASH) – A single arm clinical trial.

Author:
Shruti Tarapure; Basavaraj R. Tubaki; Siddhi Khot
Source:
Journal of Ayurveda and integrative medicine 2021 v.12 no.1 pp. 136-142
ISSN:
0975-9476
Subject:
Ayurvedic medicine; Food and Drug Administration; alanine transaminase; albumins; anorexia; aspartate transaminase; bilirubin; clinical trials; death; drug therapy; drugs; elasticity imaging techniques; fatty liver; hardness; histology; indigestion; liver; liver function
Abstract:
... Non Alcoholic Steatohepatitis (NASH) is the most severe histological form of non-alcoholic fatty liver disease (NAFLD). It progress to cirrhosis in 20% population and 40% will have death due to liver pathology. Still consensus on pharmacotherapy is yet to be evolved and till date there is no US FDA approved drug for NASH. Ayurveda formulation Katukyadi churna is explored in the possible management ...
DOI:
10.1016/j.jaim.2020.12.015

38. Enhanced water solubility, antioxidant activity, and oral absorption of hesperetin by D-α-tocopheryl polyethylene glycol 1000 succinate and phosphatidylcholine

Author:
Su-Fang Gu; Li-Ying Wang; Ying-Jie Tian; Zhu-Xian Zhou; Jian-Bin Tang; Xiang-Rui Liu; Hai-Ping Jiang; You-Qing Shen
Source:
Journal of Zhejiang University 2019 v.20 no.3 pp. 273-281
ISSN:
1673-1581
Subject:
Food and Drug Administration; absorption; antioxidant activity; bioactive compounds; bioavailability; citrus fruits; cytotoxicity; differential scanning calorimetry; drugs; health services; hesperetin; light scattering; micelles; oral administration; particle size; pharmacokinetics; phosphatidylcholines; polyethylene glycol; rats; solvents; water solubility
Abstract:
... Hesperetin, an abundant bioactive component of citrus fruits, is poorly water-soluble, resulting in low oral bioavailability. We developed new formulations to improve the water solubility, antioxidant activity, and oral absorption of hesperetin. Two nano-based formulations were developed, namely hesperetin-TPGS (D-α-tocopheryl polyethylene glycol 1000 succinate) micelles and hesperetin-phosphatidy ...
DOI:
10.1631/jzus.B1800346
PubMed:
30829014
PubMed Central:
PMC6421126

39. Formulation composition, manufacturing process, and characterization of poly(lactide-co-glycolide) microparticles

Author:
Kinam Park; Andrew Otte; Farrokh Sharifi; John Garner; Sarah Skidmore; Haesun Park; Young Kuk Jhon; Bin Qin; Yan Wang
Source:
Journal of controlled release 2021 v.329 pp. 1150-1161
ISSN:
0168-3659
Subject:
Food and Drug Administration; drugs; manufacturing; microparticles; pharmacokinetics; polymers; quality control
Abstract:
... Injectable long-acting formulations, specifically poly(lactide-co-glycolide) (PLGA) based systems, have been used to deliver drugs systemically for up to 6 months. Despite the benefits of using this type of long-acting formulations, the development of clinical products and the generic versions of existing formulations has been slow. Only about two dozen formulations have been approved by the U.S. ...
DOI:
10.1016/j.jconrel.2020.10.044

40. Herbal and Natural Dietary Products: Upcoming Therapeutic Approach for Prevention and Treatment of Hepatocellular Carcinoma

Author:
Deepa S. Mandlik; Satish K. Mandlik
Source:
Nutrition and cancer 2021 v.73 no.11-12 pp. 2130-2154
ISSN:
1532-7914
Subject:
Brassicaceae; Food and Drug Administration; adjuvants; alcohol drinking; black currants; carcinoma; death; drug therapy; drugs; etiology; fatty liver; garlic; ginger; hepatitis B; hepatoma; immunotherapy; inflammation; liver; metastasis; nutrition; oxidative stress; plums; pomegranates; toxicity; turmeric
Abstract:
... The most common tumor linked with elevated death rates is considered the hepatocellular carcinoma (HCC), sometimes called the malignant hepatoma. The initiation and progression of HCC are triggered by multiple factors like long term alcohol consumption, metabolic disorders, fatty liver disease, hepatitis B and C infection, age, and oxidative stress. Sorafenib is the merely US Food and Drug Adminis ...
DOI:
10.1080/01635581.2020.1834591

41. In vitro release testing methods for drug-releasing vaginal rings

Author:
R. Karl Malcolm; Peter Boyd; Bruce Variano; Patrick Spence; Clare F. McCoy; Diarmaid J. Murphy; Yahya H. Dallal Bashi
Source:
Journal of controlled release 2019 v.313 pp. 54-69
ISSN:
0168-3659
Subject:
Food and Drug Administration; databases; drugs; humans; markets; models; silicone; thermoplastics; vagina
Abstract:
... Drug-releasing vaginal rings are torus-shaped devices, generally fabricated from thermoplastic polymers or silicone elastomers, used to administer pharmaceutical drugs to the human vagina for periods typically ranging from three weeks to twelve months. One of the most important product performance tests for vaginal rings is the in vitro release test. Although it has been fifty years since a vagina ...
DOI:
10.1016/j.jconrel.2019.10.015

42. Making Sense of Pharmacovigilance and Drug Adverse Event Reporting: Comparative Similarity Association Analysis Using AI Machine Learning Algorithms in Dogs and Cats

Author:
Gerald Wyckoff; Xuan Xu; Reza Mazloom; Arash Goligerdian; Joshua Staley; Mohammadhossein Amini; Gerald J. Wyckoff; Jim Riviere; Majid Jaberi-Douraki
Source:
Topics in companion animal medicine 2019 v.37 pp. 100366
ISSN:
1938-9736
Subject:
Food and Drug Administration; adverse effects; algorithms; artificial intelligence; cats; clinical trials; death; dogs; drugs; health services; medicine; patients; pets; public health
Abstract:
... Drug-associated adverse events cause approximately 30 billion dollars a year of added health care expense, along with negative health outcomes including patient death. This constitutes a major public health concern. The US Food and Drug Administration (FDA) requires drug labeling to include potential adverse effects for each newly developed drug product. With the advancement in incidence of advers ...
DOI:
10.1016/j.tcam.2019.100366

43. Multi-targeting approach for nsp3, nsp9, nsp12 and nsp15 proteins of SARS-CoV-2 by Diosmin as illustrated by molecular docking and molecular dynamics simulation methodologies

Author:
Sumit Kumar; Prem Prakash Sharma; Charu Upadhyay; Prakasha Kempaiah; Brijesh Rathi; Poonam
Source:
Methods 2021 v.195 pp. 44-56
ISSN:
1046-2023
Subject:
COVID-19 infection; Food and Drug Administration; Gibbs free energy; Severe acute respiratory syndrome coronavirus 2; computer simulation; computer software; drugs; financial economics; molecular dynamics; therapeutics
Abstract:
... Novel coronavirus SARS-CoV-2continues tospread rapidly worldwide and causing serious health and economic loss. In the absence of any effective treatment, various in-silico approaches are being explored towards the therapeutic discovery against COVID-19. Targeting multiple key enzymes of SARS-CoV-2 with a single potential drug could be an important in-silico strategy to tackle the therapeutic emerg ...
DOI:
10.1016/j.ymeth.2021.02.017

44. Preparation and sterilization of an implantable drug-delivery microdevice for clinical use

Author:
Christine Dominas; Kyle Deans; Robert Packard; Oliver Jonas
Source:
MethodsX 2021 v.8 pp. 101382
ISSN:
2215-0161
Subject:
Food and Drug Administration; drugs; endotoxins; humans; medicine; therapeutics
Abstract:
... Implantable drug-delivery microdevices are a key diagnostic and therapeutic tool in medicine with increasing applications. Preparation of such combination drug-delivery devices for human studies requires the development of methods to ensure sterility, safety and integrity on both the device and drug side. Despite growing applications for these technologies, there has been a lack of clear methodolo ...
DOI:
10.1016/j.mex.2021.101382

45. Qinzhuliangxue mixture alleviates psoriasis-like skin lesions via inhibiting the IL6/STAT3 axis

Author:
Ke-shen Qu; Ying Luo; Xiao-ning Yan; Le Kuai; Yi Ru; Yue Luo; Jian-kun Song; Wan-li Ji; Bin Li; Meng Xing
Source:
Journal of ethnopharmacology 2021 v.274 pp. 114041
ISSN:
0378-8741
Subject:
angiogenesis; blood; drugs; high performance liquid chromatography; immunity; inflammation; interleukin-17; interleukin-23; keratinocytes; mice; pharmacology; psoriasis; quality control; traditional medicine
Abstract:
... Psoriasis is a chronic inflammatory skin disease mediated by immunity. Our pre-clinical studies have proved that QZLX mixture can improve patients' clinical symptoms with psoriasis without noticeable adverse reactions. In a psoriasis-like mouse model induced by imiquimod, QZLX mixture has been shown to alleviate epidermal inflammation and inhibit the hyperproliferation of keratinocytes. However, i ...
DOI:
10.1016/j.jep.2021.114041

46. Sustained drug delivery system in fish and the potential for use of PLGA microparticles: a review

Author:
J Matejkova; P Podhorec
Source:
Veterinární medicína v.64 no.7 pp. 287-293
ISSN:
0375-8427
Subject:
Food and Drug Administration; biocompatibility; biodegradability; blood; captive animals; drug delivery systems; drugs; fish; gonadotropin-releasing hormone; half life; luteinizing hormone; polymers; reproduction; reproductive disorders; semen
Abstract:
... Many fish species display some form of reproductive disorder in captivity. Captive fish reared in conditions outside the natural spawning environment show a failure of the pituitary to release the maturational gonadotropin luteinizing hormone thus necessitating administration of the hormone to induce spawning. A controlled sustained-release delivery system can conquer the issue of short half-life ...
DOI:
10.17221/161/2018-vetmed

47. Alzheimer's disease; a review of the pathophysiological basis and therapeutic interventions

Author:
A.A.D.T. Abeysinghe; R.D.U.S. Deshapriya; C. Udawatte
Source:
Life sciences 2020 v.256 pp. 117996
ISSN:
0024-3205
Subject:
Alzheimer disease; Food and Drug Administration; cognition; disease progression; drug development; drugs; etiology; memory; neurodegenerative diseases; pathogenesis; therapeutics
Abstract:
... Alzheimer's disease (AD) is a neurodegenerative disorder and is identified as the most common cause for dementia. Despite huge global economic burden and the impact on the close family of the patients, there is no definitive cure and thus, improved treatment methods are of need. While memory and cognition are severely affected in AD, exact etiology is yet unknown. The β-Amyloid plaque formation an ...
DOI:
10.1016/j.lfs.2020.117996

48. Anti-echinococcal activity of menthol and a novel prodrug, menthol-pentanol, against Echinococcus multilocularis

Author:
Julia Fabbri; Camila M. Clemente; Natalia Elissondo; Guillermo Gambino; Soledad Ravetti; Lisandro Y. Hergert; Santiago D. Palma; María C. Elissondo
Source:
Acta tropica 2020 v.205 pp. 105411
ISSN:
0001-706X
Subject:
Echinococcus multilocularis; Food and Drug Administration; GRAS substances; albendazole; antiparasitic properties; bioavailability; carbonates; cosmetics; drug therapy; drugs; echinococcosis; gastronomy; industry; lipophilicity; menthol; patients; pentanols; pharmacokinetics; tapeworms; toxicity; zoonoses
Abstract:
... Alveolar echinococcosis is one of the most dangerous parasitic zoonoses. This disease, widely distributed in the northern hemisphere, is caused by the metacestode stage of the tapeworm Echinococcus multilocularis. All surgical and non-surgical patients should perform chemotherapy with benzimidazoles, mainly with albendazole. However, the efficacy of albendazole is variable due to its deficient pha ...
DOI:
10.1016/j.actatropica.2020.105411

49. Antimicrobial use data collection in animal agriculture

Author:
Susan J. Bright‐Ponte
Source:
Zoonoses and public health 2020 v.67 Suppl S1 pp. 1-5
ISSN:
1863-1959
Subject:
Food and Drug Administration; cattle; data collection; drug resistance; drugs; feedlots; humans; medicine; public health; swine; veterinary medicine; zoonoses
Abstract:
... Antimicrobial drug use can contribute to the emergence of antimicrobial drug‐resistant organisms; therefore, judicious use of this important category of drugs is critical in both human and animal medicine to slow the development and spread of resistance. The US Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) is committed to advancing efforts to implement good antimicrobial ...
DOI:
10.1111/zph.12771

50. Baohuoside i suppresses breast cancer metastasis by downregulating the tumor-associated macrophages/C-X-C motif chemokine ligand 1 pathway

Author:
Shengqi Wang; Neng Wang; Xiaowei Huang; Bowen Yang; Yifeng Zheng; Juping Zhang; Xuan Wang; Yi Lin; Zhiyu Wang
Source:
Phytomedicine 2020 v.78 pp. 153331
ISSN:
0944-7113
Subject:
Danio rerio; Food and Drug Administration; bioactive compounds; breast neoplasms; breasts; cancer therapy; chemical structure; coculture; drugs; embryotoxicity; fractionation; humans; ligands; metastasis; mice; models; molecular biology; phenotype; secretion; teratogenicity; xenotransplantation; China
Abstract:
... Breast cancer is the most common malignancy in women and metastasis is the leading cause of breast cancer-related deaths. Our previous studies have shown that XIAOPI formula, a newly approved drug by the State Food and Drug Administration of China (SFDA), can dramatically inhibit breast cancer metastasis by modulating the tumor-associated macrophages/C-X-C motif chemokine ligand 1 (TAMs/CXCL1) pat ...
DOI:
10.1016/j.phymed.2020.153331