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1. Analysis of secondary pharmacology assays received by the US Food and Drug Administration

Author:
Christina Scott; Andrew Dodson; Muriel Saulnier; Kevin Snyder; Rebecca Racz
Source:
Journal of pharmacological and toxicological methods 2022 v.117 pp. 107205
ISSN:
1056-8719
Subject:
Food and Drug Administration; cost effectiveness; drugs; histamine; humans; pharmacology; sodium channels; toxicology
Abstract:
... Secondary pharmacology studies are a time-efficient and cost-effective method for determining the safety profile of a potential new drug before it enters human trials. The results of these multi-target screens are commonly submitted with Investigational New Drug (IND) applications, but there currently is little guidance on how such information is presented and which targets are chosen for testing. ...
DOI:
10.1016/j.vascn.2022.107205

2. Butyrolactone I attenuates inflammation in murine NASH by inhibiting the NF-κB signaling pathway

Author:
Chen Tian-qi; Deng Yan-fang; Wang Yan-yan; Zhang Yong-hui
Source:
Biochemical and biophysical research communications 2022 v.626 pp. 167-174
ISSN:
0006-291X
Subject:
Aspergillus terreus; Food and Drug Administration; active ingredients; anti-inflammatory activity; blood serum; diet; drugs; fatty liver; inflammation; lipopolysaccharides; liver cirrhosis; mice; oxidative stress; research
Abstract:
... Nonalcoholic steatohepatitis (NASH) is the development of non-alcoholic fatty liver disease (NAFLD) and a key element in the exacerbation of NAFLD. Since there are currently no drugs approved by the U.S. Food and Drug Administration to treat this disease, the search for treatments that can be translated into clinical use is urgent. Butyrolactone I (BLI), isolated from Aspergillus terreus, is an ac ...
DOI:
10.1016/j.bbrc.2022.07.050

3. Controllable preparation of bioactive open porous microspheres for tissue engineering

Author:
Anqi Lin; Shengyang Liu; Lan Xiao; Yingying Fu; Changsheng Liu; Yulin Li
Source:
Journal of materials chemistry B 2022 v.10 no.34 pp. 6464-6471
ISSN:
2050-7518
Subject:
Food and Drug Administration; bioactive properties; biocompatibility; biodegradability; cell proliferation; drugs; employment; medicine; microparticles; micropores; surface area; transportation
Abstract:
... Biodegradable microspheres have been widely applied as cell carriers for tissue engineering and regenerative medicine. However, most cell carriers only have a simple planar structure and show poor biological activity and cell adherence, resulting in low cell density and unfavorable application effect. How to develop size-controllable microspheres with an open-porous structure remains a challenge, ...
DOI:
10.1039/d2tb01198k

4. 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

5. 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

6. 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

7. 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

8. 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

9. Jinhua Qinggan granules attenuates acute lung injury by promotion of neutrophil apoptosis and inhibition of TLR4/MyD88/NF-κB pathway

Author:
Yanhui Zhu; Qianqian Han; Lei Wang; Baiyan Wang; Jianshuang Chen; Bangrong Cai; Can Wu; Xiali Zhu; Fugang Liu; Deen Han; Haoran Dong; Yongyan Jia; Yalin Liu
Source:
Journal of ethnopharmacology 2022 pp. 115763
ISSN:
0378-8741
Subject:
COVID-19 infection; Food and Drug Administration; Orthomyxoviridae; Toll-like receptor 4; Western blotting; apoptosis; caspases; drugs; flow cytometry; fluorescent antibody technique; histology; histopathology; inflammation; influenza; interleukin-6; intraperitoneal injection; lipopolysaccharides; lungs; mice; mitochondria; models; morbidity; neutrophils; protein content; protein synthesis; survival rate; traditional medicine; viruses; China
Abstract:
... Acute lung injury (ALI) is one of the fatal complications of respiratory virus infections such as influenza virus and coronavirus, which has high clinical morbidity and mortality. Jinhua Qinggan granules (JHQG) has been approved by China Food and Drug Administration in the treatment of H1N1 influenza and mild or moderate novel coronavirus disease 2019 (COVID-19), which is an herbal formula develop ...
DOI:
10.1016/j.jep.2022.115763

10. 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

11. Natural salicylaldehyde for fungal and pre- and post-emergent weed control

Author:
Kim Jong H.; Chan Kathleen L.
Source:
Applied sciences 2022 v.12 no.8 pp. -
ISSN:
2076-3417
Subject:
Food and Drug Administration; active ingredients; air; antifungal properties; carbon sequestration; databases; drugs; environmental degradation; fumigants; fungi; heat; hulls; hydroxybenzaldehyde; pesticides; postemergent weed control; soil; solar radiation; sustainable agriculture; synergism; trees
Abstract:
... A sustainable, alternative weed control strategy is developed using salicylaldehyde (SA; 2-hydroxybenzaldehyde) as an active ingredient. SA is a natural, redox-active small molecule listed as a Generally Recognized As Safe food additive by the European Food Safety Authority and the United States Food and Drug Administration. The repurposing of SA determined that SA possesses both pre- and post-eme ...
Handle:
10113/7858470
DOI:
10.3390/app12083749

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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

23. 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

24. 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

25. 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

26. 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

27. 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

28. 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

29. 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

30. 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

31. 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

32. Modulators of histone demethylase JMJD1C selectively target leukemic stem cells

Author:
Yong Yang; Xinjing Zhang; Xiaoyan Zhang; Yishu Wang; Xintong Wang; Linda Hu; Yao Zhao; Haihua Wang; Zhanju Wang; Haiying Wang; Lin Wang; Wilhelm G. Dirks; Hans G. Drexler; Xin Xu; Zhenbo Hu
Source:
FEBS Open Bio 2021 v.11 no.1 pp. 265-277
ISSN:
2211-5463
Subject:
Food and Drug Administration; blood; cell culture; cell proliferation; drugs; genes; histone demethylases; histones; liquids; lysine; myeloid leukemia; surface plasmon resonance; umbilical cord
Abstract:
... Leukemic stem cells (LSCs) comprise a very rare cell population that results in the development of acute myeloid leukemia. The selective targeting of drivers in LSCs with small molecule inhibitors holds promise for treatment of acute myeloid leukemia. Recently, we reported the identification of inhibitors of the histone lysine demethylase JMJD1C that preferentially kill MLL rearranged acute leukem ...
DOI:
10.1002/2211-5463.13054

33. 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

34. 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

35. 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

36. 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

37. 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

38. 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

39. 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

40. 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

41. 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

42. 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

43. 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

44. 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

45. 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

46. Cannabidiol (CBD) in Dietary Supplements: Perspectives on Science, Safety, and Potential Regulatory Approaches

Author:
Larry A. Walker; Igor Koturbash; Rick Kingston; Mahmoud A. ElSohly; Charles Ryan Yates; Bill J. Gurley; Ikhlas Khan
Source:
Journal of dietary supplements 2020 v.17 no.5 pp. 493-502
ISSN:
1939-022X
Subject:
Food and Drug Administration; cannabidiol; drugs; issues and policy
Abstract:
... The proliferation in the last few years of cannabidiol (CBD)-containing products in the U.S. markets has been greatly accelerated by changes in the regulatory environment, and by perceptions of their health benefits and presumed safety. The result has been aggressive marketing of many types of products, some of dubious quality, making or implying drug-type claims. The recent approval by the U.S. F ...
DOI:
10.1080/19390211.2020.1777244

47. Cannabidiol and Other Cannabinoids: From Toxicology and Pharmacology to the Development of a Regulatory Pathway

Author:
Igor Koturbash; Douglas MacKay
Source:
Journal of dietary supplements 2020 v.17 no.5 pp. 487-492
ISSN:
1939-022X
Subject:
Cannabis sativa; Food and Drug Administration; cannabidiol; dietary supplements; drug resistance; drugs; food composition; hemp; ingredients; markets; pharmacology; toxicology
Abstract:
... Cannabidiol (CBD) is a non-psychotropic constituent of Cannabis sativa that has grown in popularity during the last decade. CBD is the active component of EPIDIOLEX®, a U.S. Food and Drug Administration (FDA)-approved drug designed for the treatment of drug-resistant pediatric epileptic seizures associated with several rare syndromes. Furthermore, CBD has been proposed as a treatment for a number ...
DOI:
10.1080/19390211.2020.1796886

48. Comprehensive assessment of side effects in COVID-19 drug pipeline from a network perspective

Author:
Qihui Wu; Xiude Fan; Honghai Hong; Yong Gu; Zhihong Liu; Shuhuan Fang; Qi Wang; Chuipu Cai; Jiansong Fang
Source:
Food and chemical toxicology 2020 v.145 pp. 111767
ISSN:
0278-6915
Subject:
COVID-19 infection; Food and Drug Administration; Severe acute respiratory syndrome coronavirus 2; drugs; hepatotoxicity; humans; lungs; medical treatment; nephrotoxicity; neurotoxicity; public health; toxicology
Abstract:
... Currently, coronavirus disease 2019 (COVID-19), has posed an imminent threat to global public health. Although some current therapeutic agents have showed potential prevention or treatment, a growing number of associated adverse events have occurred on patients with COVID-19 in the course of medical treatment. Therefore, a comprehensive assessment of the safety profile of therapeutic agents agains ...
DOI:
10.1016/j.fct.2020.111767

49. Dataset of certified food dye levels in over the counter medicines and vitamins intended for consumption by children and pregnant women

Author:
Arlie L. Lehmkuhler; Mark D. Miller; Asa Bradman; Rosemary Castorina; Alyson E. Mitchell
Source:
Data in Brief 2020 v.32 pp. 106073
ISSN:
2352-3409
Subject:
Food and Drug Administration; cold; cough; data collection; diodes; drugs; food colorants; high performance liquid chromatography; hypersensitivity; markets; pain; photometry; toxicology
Abstract:
... Food, Drug, & Cosmetic (FD&C) dyes can be found in various products outside of food that are consumed by children. The amount of FD&C dyes used in commercial products is proprietary. Determining the contribution of dye intake from commercial products requires direct assessment of FD&C dyes in the products. This dataset contains the raw data of HPLC peak areas, absolute values, averages, SDs and % ...
DOI:
10.1016/j.dib.2020.106073

50. Development and validation of a rapid, robust and sensitive UPLC-QQQ-MS/MS method for simultaneous quantification of GSH metabolism in lung cancer cells

Author:
Yu-Fei Zhang; Yang Wang; Ke-Ren Zhang; Hui-Min Lei; Ya-Bin Tang; Liang Zhu
Source:
Journal of chromatography 2020 v.1148 pp. 122145
ISSN:
1570-0232
Subject:
Food and Drug Administration; cultured cells; cysteine; cystine; derivatization; detection limit; disease resistance; drugs; glutamic acid; glutamine; glutathione; glycine (amino acid); homeostasis; lung neoplasms; metabolism; metabolites; metabolomics; neoplasm cells; quality control; tandem mass spectrometry; therapeutics; ultra-performance liquid chromatography
Abstract:
... Changes in cellular metabolism accompany tumor therapeutic resistance. Metabolite concentrations specifically reflect the cellular state. Glutathione (GSH) metabolism maintains the redox homeostasis while also confers therapeutic resistance to cancer cells. However, analytical methods for studying GSH metabolism rely on high-resolution-based untargeted metabolomics. Since the aim of untargeted met ...
DOI:
10.1016/j.jchromb.2020.122145