Biowaiver monographs for immediate release solid oral dosage forms based on biopharmaceutics classification system (BCS) literature data: Verapamil hydrochloride, propranolol hydrochloride, and atenolol

2004 ◽  
Vol 93 (8) ◽  
pp. 1945-1956 ◽  
Author(s):  
H. Vogelpoel ◽  
J. Welink ◽  
G.L. Amidon ◽  
H.E. Junginger ◽  
K.K. Midha ◽  
...  
Keyword(s):  
Classification System ◽  
Immediate Release ◽  
Dosage Forms ◽  
Biopharmaceutics Classification System ◽  
Oral Dosage ◽  
Propranolol Hydrochloride ◽  
Verapamil Hydrochloride ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms ◽  
Biopharmaceutics Classification

Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Piroxicam

2014 ◽  
Vol 103 (2) ◽  
pp. 367-377 ◽  
Author(s):  
Igor E. Shohin ◽  
Julia I. Kulinich ◽  
Galina V. Ramenskaya ◽  
Bertil Abrahamsson ◽  
Sabine Kopp ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Quinine Sulfate

2012 ◽  
Vol 101 (2) ◽  
pp. 499-508 ◽  
Author(s):  
Stefanie Strauch ◽  
Jennifer B. Dressman ◽  
Vinod P. Shah ◽  
Sabine Kopp ◽  
James E. Polli ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Quinine Sulfate ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

scholarly journals Requirements for Additional Strength Biowaivers for Modified Release Solid Oral Dosage Forms in International Pharmaceutical Regulators Programme Participating Regulators and Organisations: Differences and Commonalities

2021 ◽  
Vol 24 ◽  
pp. 548-562
Author(s):  
Matthias Shona Roost ◽  
Henrike Potthast ◽  
Chantal Walther ◽  
Alfredo García-Arieta ◽  
Ivana Abalos ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Quantitative Composition ◽  
Modified Release ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms

This article describes an overview of waivers of in vivo bioequivalence studies for additional strengths in the context of the registration of modified release generic products and is a follow-up to the recent publication for the immediate release solid oral dosage forms. The current paper is based on a survey among the participating members of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Program (IPRP) regarding this topic. Most jurisdictions consider the extrapolation of bioequivalence results obtained with one (most sensitive) strength of a product series as less straightforward for modified release products than for immediate release products. There is consensus that modified release products should demonstrate bioequivalence not only in the fasted state but also in the fed state, but differences exist regarding the necessity of additional multiple dose studies. Fundamental differences between jurisdictions are revealed regarding requirements on the quantitative composition of different strengths and the differentiation of single and multiple unit dosage forms. Differences in terms of in vitro dissolution requirements are obvious, though these are mostly related to possible additional comparative investigations rather than regarding the need for product-specific methods. As with the requirements for immediate release products, harmonization of the various regulations for modified release products is highly desirable to conduct the appropriate studies from a scientific point of view, thus ensuring therapeutic equivalence.

scholarly journals Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron

2019 ◽  
Vol 108 (10) ◽  
pp. 3157-3168
Author(s):  
Gopal Singh Rajawat ◽  
Tejashree Belubbi ◽  
Mangal S. Nagarsenker ◽  
Bertil Abrahamsson ◽  
Rodrigo Cristofoletti ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms
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