NDLI: Optimizing Metrics for the Assessment of Bioequivalence Between Topical Drug Products

Content Provider	Springer Nature Link
Author	N’Dri Stempfer, Berthe Navidi, William C. Guy, Richard H. Bunge, Annette L.
Copyright Year	2008
Abstract	Stratum corneum tape stripping post-application of a drug product followed by analysis of the active agent in this tissue layer is an approach being seriously considered for the comparative assessment of topical bioavailability. Key issues revolve around how best to perform this experiment and interpret the data.Using previously published results from a comparative study of three 0.025% tretinoin gel products, alternative data analysis approaches are presented that may render the technique more accessible to the evaluation of new and generic topical dosage forms.For the tretinoin gel study, the conclusions for bioequivalence from measurements of drug levels at only one uptake and one clearance time were the same as those from the original study, which required measurements at eight different treatment times. Furthermore, comparisons of drug levels at one uptake and one clearance time discriminated differences in bioequivalence for clearance and uptake, which had previously been missed. Half-life estimates, derived from time course data of drug clearance, can be related to lag time for drug penetration through the SC.This new data analysis demonstrates that comparative bioequivalence might be assessed more easily.
Starting Page	1621
Ending Page	1630
Page Count	10
File Format	PDF
ISSN	07248741
Journal	Pharmaceutical Research
Volume Number	25
Issue Number	7
e-ISSN	1573904X
Language	English
Publisher	Springer US
Publisher Date	2008-05-01
Publisher Place	Boston
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Biomedical Engineering Medical Law Biochemistry Pharmacy Pharmacology/Toxicology
Content Type	Text
Resource Type	Article
Subject	Organic Chemistry Pharmacology Molecular Medicine Pharmacology (medical) Biotechnology Pharmaceutical Science

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Improved Bioequivalence Assessment of Topical Dermatological Drug Products Using Dermatopharmacokinetics

Bioequivalence for Topical Products—An Update

Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

Assessment of Topical Bioequivalence Using Dermal Microdialysis and Tape Stripping Methods

Bioequivalence of Topical Dermatological Dosage Forms-Methods of Evaluation of Bioequivalence

Novel Direct Curve Comparison Metrics for Bioequivalence

Evaluation of the Bioequivalence of Highly-Variable Drugs and Drug Products

Bioequivalence Methodologies for Topical Drug Products: In Vitro and Ex Vivo Studies with a Corticosteroid and an Anti-Fungal Drug

Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products

Optimizing Metrics for the Assessment of Bioequivalence Between Topical Drug Products

Similar Documents

Improved Bioequivalence Assessment of Topical Dermatological Drug Products Using Dermatopharmacokinetics

Bioequivalence for Topical Products—An Update

Current Challenges in Bioequivalence, Quality, and Novel Assessment Technologies for Topical Products

Assessment of Topical Bioequivalence Using Dermal Microdialysis and Tape Stripping Methods

Bioequivalence of Topical Dermatological Dosage Forms-Methods of Evaluation of Bioequivalence

Novel Direct Curve Comparison Metrics for Bioequivalence

Evaluation of the Bioequivalence of Highly-Variable Drugs and Drug Products

Bioequivalence Methodologies for Topical Drug Products: In Vitro and Ex Vivo Studies with a Corticosteroid and an Anti-Fungal Drug

Assessment of Value and Applications of In Vitro Testing of Topical Dermatological Drug Products

Optimizing Metrics for the Assessment of Bioequivalence Between Topical Drug Products