In vitro and in vivo testing and correlation for oral controlled/ modified release dosage forms. report of the 2nd workshop held December 1988, Washington, DC. U.S.A.

1990 ◽  
Vol 14 (1) ◽  
pp. 95-106 ◽  
Author(s):  
Jerome P. Skelly ◽  
Gordon L. Amidon ◽  
William H. Barr ◽  
Leslie Z. Benet ◽  
James E. Carter ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Washington Dc ◽  
Modified Release ◽  
In Vivo Testing

scholarly journals Report of the workshop on: in vitro and in vivo testing and correlation for oral controlled/modified release dosage forms

1990 ◽  
Vol 63 (2) ◽  
pp. 83-93 ◽  
Author(s):  
Jerome P. Skelly ◽  
Gordon L. Amidon ◽  
William H. Barr ◽  
Leslie Z. Benet ◽  
James E. Carter ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Modified Release ◽  
In Vivo Testing

Report of the Workshop on In Vitro and In Vivo Testing and Correlation for Oral Controlled/Modified-Release Dosage Forms

1990 ◽  
Vol 79 (9) ◽  
pp. 849-854 ◽  
Author(s):  
Jerome P. Skelley ◽  
Gordon L. Amidon ◽  
William H. Barr ◽  
Leslie Z. Benet ◽  
James E. Carter ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Modified Release ◽  
In Vivo Testing

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 Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect

2015 ◽  
Vol 65 (4) ◽  
pp. 427-441 ◽  
Author(s):  
Marija Ilić ◽  
Ivan Kovačević ◽  
Jelena Parojčić
Keyword(s):  
In Silico ◽  
Food Effect ◽  
Drug Product ◽  
Dosage Forms ◽  
In Vitro Dissolution ◽  
Dissolution Testing ◽  
Modified Release ◽  
In Vivo Delivery

Abstract With the increased reliance on in vitro dissolution testing as an indicator of in vivo drug behavior and the trend towards the in silico modeling of dosage form performance, the need for bioperformance dissolution methodology development has been enhanced. Determination of the in vivo drug delivery profile is essential for the bioperformance dissolution test development and in vitro/in vivo correlation modeling, as well as the understanding of absorption mechanisms. The aim of this study was to compare different methods in terms of their usefulness and applicability in deciphering in vivo delivery of nifedipine administered in modified release dosage forms. A detailed survey of publications on nifedipine pharmacokinetics was done and used to identify the magnitude of food effect. In vitro dissolution testing was performed under various experimental conditions. Obtained results indicate the potential for using the developed in silico model coupled with discriminative in vitro dissolution data for identification of the in vivo drug product behavior

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