In Vitro–In Vivo Correlation: A Regulatory Perspective with Case Studies

2007 ◽  
pp. 177-195 ◽  
Author(s):  
Patrick J. Marroum
Keyword(s):  
Case Studies ◽  
Regulatory Perspective

scholarly journals Case Studies for Practical Food Effect Assessments across BCS/BDDCS Class Compounds using In Silico, In Vitro, and Preclinical In Vivo Data

2012 ◽  
Vol 15 (1) ◽  
pp. 143-158 ◽  
Author(s):  
Tycho Heimbach ◽  
Binfeng Xia ◽  
Tsu-han Lin ◽  
Handan He
Keyword(s):  
Case Studies ◽  
In Silico ◽  
Food Effect

Regulatory Perspective on in Vitro Assays as Predictors of Phototoxicity and Photo Co-Carcinogenicity

1998 ◽  
Vol 17 (5) ◽  
pp. 571-575 ◽  
Author(s):  
Amy L. Ellis
Keyword(s):  
Mammalian Cells ◽  
Hairless Mouse ◽  
In Vitro Assays ◽  
In Vitro Tests ◽  
Drug Products ◽  
Drug Classes ◽  
Wide Range ◽  
Regulatory Perspective

Drugs from a variety of chemical classes used for a wide range of therapeutic indications can be photosensitizers in humans. Several drugs are phototoxic in animal models as well; there are no nonclinical data for many. In vitro tests have been developed as predictors of phototoxicity and although they have been used as screens, none have replaced the in vivo tests done in rodents (usually mice or guinea pigs) since these have been good predictors of clinical phototoxicity. Some phototoxic drug classes are co-carcinogens with ultraviolet radiation (UVA and/or UVB) in hairless mice, specifically psoralens, retinoids, and fluo-roquinolones. Treatment with 8-methoxypsoralen and ultraviolet A radiation for psoriasis is also carcinogenic in humans. It has been suggested that in vitro photogenotoxicity assays using microorganisms or mammalian cells may be predictive of photo co-carcinogenicity. Some attractions of these in vitro assays, compared to the hairless mouse photo co-carcinogenicity assay, are their generally shorter duration and lower cost as well as reducing the number of animals used in research. Currently, personnel at the Food and Drug Administration (FDA) are examining the available data on phototoxicity, photogenotoxicity, and photo co-carcinogenicity to determine how this information can best be used toregulate and label drug products, and considering which assays should be recommended under specific circumstances.

scholarly journals Remdesivir for COVID-19: A review of pharmacology, mechanism of action, in-vitro activity and clinical use based on available case studies

2020 ◽  
Vol 10 (4-s) ◽  
pp. 264-270
Author(s):  
Kirtikumar Chandulal Badgujar ◽  
Avadheshkumar H. Ram ◽  
Rahoul Zanznay ◽  
Hemant Kadam ◽  
Vivek C. Badgujar
Keyword(s):  
Adverse Events ◽  
Case Studies ◽  
Mechanism Of Action ◽  
Clinical Results ◽  
Clinical Use ◽  
Literature Study ◽  
Ongoing Research ◽  
In Vitro Inhibition

Remdesivir as a drug attracted a very serious consideration of whole Globe in treatment of the pandemic disease COVID-19. More recently published in-vitro inhibition activity and in-vivo case studies were showing promising clinical results and outcome of effective inhibition of SARS-CoV-2 virus by the use of remdesivir. However at the same time, use of the remdesivir showed substantial detrimental adverse events in patients which needs a special attention during treatment course of COVID-19. Thus, the use of remdesivir in treatment of COVID-19 is having current international interest although some more clinical evidences are still necessary in order to understand the actual efficiency and mechanism of remdesivir against COVID-19. In view of this, the present literature study spotlight the current ongoing research related to use of remdesivir which includes (i) pharmacology of remdesivir, (ii) mechanism of action of remdesivir (iii) in-vitro inhibition of remdesivir against SARS-CoV-2 virus, (iv) in-vivo analysis and clinical use of remdesivir against COVID-19. Finally possible adverse events (of use of remdesivir) are also discussed considering the pharmacovigilance concern. Keywords: Remdesivir; COVID-19; Remdesivir side effects, Remdesivir pharmacology; SARS-CoV-2 virus

Comparison of in vitro tests at various levels of complexity for the prediction of in vivo performance of lipid-based formulations: Case studies with fenofibrate

2014 ◽  
Vol 86 (3) ◽  
pp. 427-437 ◽  
Author(s):  
Brendan T. Griffin ◽  
Martin Kuentz ◽  
Maria Vertzoni ◽  
Edmund S. Kostewicz ◽  
Yang Fei ◽  
...  
Keyword(s):  
Case Studies ◽  
In Vitro Tests

In vitro and in vivo percutaneous absorption of topical dosage forms: case studies

2005 ◽  
Vol 291 (1-2) ◽  
pp. 11-19 ◽  
Author(s):  
I. Csóka ◽  
E. Csányi ◽  
G. Zapantis ◽  
E. Nagy ◽  
A. Fehér-Kiss ◽  
...  
Keyword(s):  
Case Studies ◽  
Percutaneous Absorption ◽  
Dosage Forms ◽  
Topical Dosage ◽  
Topical Dosage Forms ◽  
In Vivo Percutaneous Absorption

scholarly journals Applications of In Vitro–In Vivo Correlations in Generic Drug Development: Case Studies

2015 ◽  
Vol 17 (4) ◽  
pp. 1035-1039 ◽  
Author(s):  
Paramjeet Kaur ◽  
Xiaojian Jiang ◽  
John Duan ◽  
Ethan Stier
Keyword(s):  
Drug Development ◽  
Case Studies ◽  
Generic Drug
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