Brand-to-Generic Therapeutic Equivalence Analysis of Modified-Release (MR) Oral Drug Products

2016 ◽  
Author(s):  
Hong Wen
Keyword(s):  
Oral Drug ◽  
Therapeutic Equivalence ◽  
Modified Release ◽  
Drug Products

scholarly journals Do Regulatory Bioequivalence Requirements Adequately Reflect the Therapeutic Equivalence of Modified-Release Drug Products?

2010 ◽  
Vol 13 (1) ◽  
pp. 107 ◽  
Author(s):  
Laszlo Endrenyi ◽  
Laszlo Tothfalusi
Keyword(s):  
Potential Usefulness ◽  
Concentration Profiles ◽  
Therapeutic Equivalence ◽  
Modified Release ◽  
Regulatory Requirements ◽  
Partial Auc ◽  
Drug Products ◽  
Release Drug

Purpose. To demonstrate that current regulatory requirements for bioequivalence (BE) do not always reflect therapeutic equivalence. To investigate the potential usefulness of an additional metric, the partial AUC. Methods. Pharmacokinetic information was reviewed and evaluated on the pharmacokinetics of modified-release methylphenidate and nifedipine products. Results. In studies of modified-release products of methylphenidate as well as of nifedipine, traditional regulatory criteria found two formulations to be bioequivalent even though their concentration profiles strongly diverged during the period of absorption. An additional metric, partial AUC, discriminated strongly between the concentrations of the drug products. Conclusions. The current regulatory criteria for the acceptance of BE do not always reflect the therapeutic equivalence of modified-release drug products. With some modified-release products, the application of an additional metric, the partial AUC, yields an improved discriminatory representation.

Past, Present, and Future of Bioequivalence: Improving Assessment and Extrapolation of Therapeutic Equivalence for Oral Drug Products

2018 ◽  
Vol 107 (10) ◽  
pp. 2519-2530 ◽  
Author(s):  
Rodrigo Cristofoletti ◽  
Malcolm Rowland ◽  
Lawrence J. Lesko ◽  
Henning Blume ◽  
Amin Rostami-Hodjegan ◽  
...  
Keyword(s):  
Oral Drug ◽  
Therapeutic Equivalence ◽  
Drug Products

Sample Preparation Composite and Replicate Strategy for Assay of Solid Oral Drug Products

2014 ◽  
Vol 86 (24) ◽  
pp. 11930-11936 ◽  
Author(s):  
Brent Harrington ◽  
Beverly Nickerson ◽  
Michele Xuemei Guo ◽  
Marc Barber ◽  
David Giamalva ◽  
...  
Keyword(s):  
Sample Preparation ◽  
Oral Drug ◽  
Drug Products

Report from the “3rd International Symposium on BA/BE of Oral Drug Products: Biopharmaceutics meets Galenics”

2020 ◽  
Vol 56 ◽  
pp. 101274
Author(s):  
P. Paixão ◽  
K. Kawakami ◽  
M. Bermejo ◽  
Y. Tsume ◽  
N. Silva ◽  
...  
Keyword(s):  
International Symposium ◽  
Oral Drug ◽  
Drug Products

scholarly journals Gastrointestinal release behaviour of modified-release drug products: Dynamic dissolution testing of mesalazine formulations

2015 ◽  
Vol 484 (1-2) ◽  
pp. 103-108 ◽  
Author(s):  
Alvaro Goyanes ◽  
Grace B. Hatton ◽  
Hamid A. Merchant ◽  
Abdul W. Basit
Keyword(s):  
Dissolution Testing ◽  
Modified Release ◽  
Drug Products ◽  
Release Drug

ChemInform Abstract: Package Selection for Moisture Protection for Solid, Oral Drug Products

ChemInform ◽  
2011 ◽  
Vol 42 (6) ◽  
pp. no-no
Author(s):  
Kenneth C. Waterman ◽  
Bruce C. MacDonald
Keyword(s):  
Oral Drug ◽  
Drug Products ◽  
Moisture Protection ◽  
Selection For

scholarly journals Unraveling the behavior of oral drug products inside the human gastrointestinal tract using the aspiration technique: History, methodology and applications

2020 ◽  
Vol 155 ◽  
pp. 105517
Author(s):  
Patrick Augustijns ◽  
Maria Vertzoni ◽  
Christos Reppas ◽  
Peter Langguth ◽  
Hans Lennernäs ◽  
...  
Keyword(s):  
Gastrointestinal Tract ◽  
Oral Drug ◽  
Human Gastrointestinal Tract ◽  
Drug Products ◽  
Aspiration Technique
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