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

2019 ◽  
Vol 22 ◽  
pp. 486-500
Author(s):  
Christopher Crane ◽  
Gustavo Mendes Lima Santos ◽  
Eduardo Agostinho Freitas Fernandes ◽  
Craig Simon ◽  
Andrew Tam ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Quantitative Composition ◽  
The Usa ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms ◽  
Country Specific ◽  
The Eu

In relation to the registration of generic products, waivers of in vivo bioequivalence studies (biowaivers) are considered in three main cases: certain dosage forms for which bioequivalence is self-evident (e.g. intravenous solutions), biowaivers based on the Biopharmaceutics Classification System and biowaivers for additional strengths with respect to the strength for which in vivo bioequivalence has been shown. The objective of this article is to describe the differences and commonalities in biowaivers for additional strengths of immediate release solid oral dosage forms between the participating members of the International Pharmaceutical Regulators Program (IPRP). The requirements are based on five main aspects; the pharmacokinetics of the drug substance, the manufacturing process, the qualitative and quantitative composition of the different strengths, and the comparative dissolution profiles. For the pharmacokinetic aspects, many regulators/agencies have the same requirements. All strengths must be manufactured with the same process, although a few regulators/agencies accept small differences. In relation to the formulation aspects, the data required breaks down into three major approaches based initially on one of those of the EU, the USA or Japan, but there are some differences in these three major approaches with some country specific interpretations. Most regulators/agencies also have the same requirements for the dissolution data, though there are some notable exceptions.

scholarly journals FDA Guidance for Industry 1 Extended Release Solid Oral Dosage forms: Development, Evaluation, and Application of In Vitro/In Vivo Correlations

1997 ◽  
Vol 4 (4) ◽  
pp. 23-32 ◽  
Author(s):  
Henry Malinowski ◽  
Patrick Marroum ◽  
Venkata Ramana Uppoor ◽  
William Gillespie ◽  
Hae-Young Ahn ◽  
...  
Keyword(s):  
Extended Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Fda Guidance ◽  
Solid Oral Dosage Forms ◽  
Development Evaluation ◽  
Oral Dosage Forms

scholarly journals A Survey of the Regulatory Requirements for the Waiver of In Vivo Bioequivalence Studies of Generic Products in Certain Dosage Forms by Participating Regulators and Organisations of the International Pharmaceutical Regulators Programme

2021 ◽  
Vol 24 ◽  
pp. 113-126
Author(s):  
Alfredo Garcia Arieta ◽  
Craig Simon ◽  
Andrew Tam ◽  
Gustavo Mendes Lima Santos ◽  
Eduardo Agostinho Freitas Fernandes ◽  
...  
Keyword(s):  
Immediate Release ◽  
Dosage Forms ◽  
Oral Dosage ◽  
Regulatory Requirements ◽  
Intravenous Injections ◽  
Soft Gelatin Capsules ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms ◽  
Regulatory Convergence

The requirements to waive in vivo bioequivalence studies for immediate release solid oral dosage forms based on the Biopharmaceutics Classifications System (BCS) are well known, and biowaivers[1] for other types of oral dosage forms based on pre-defined criteria may also be acceptable. Similarly, biowaivers for dosage forms such as injectable products may also be allowed if certain criteria are met. The current paper summarises the biowaiver requirements for oral solutions and suspensions, soft gelatin capsules and injectable products (intravenous injections, subcutaneous and intramuscular injections, emulsions for injection and micellar solutions for injection) among the participants of the Bioequivalence Working Group for Generics (BEWGG) of the International Pharmaceutical Regulators Programme (IPRP). A review of the requirements indicated that there was a trend towards convergence when the dosage form became less complex; however, the most common approach used by each of the jurisdictions was a case-by-case approach given that most jurisdictions do not have well defined guidelines to support all possible scenarios. Even in the simplest case of intravenous solutions, the acceptability of qualitative changes in excipients differ between the IPRP members.  Notwithstanding the differences, the dissemination of the information is a first step towards regulatory convergence regarding biowaivers for certain dosage forms and should be useful for pharmaceutical companies currently developing generic medicinal products for IPRP jurisdictions.  

scholarly journals Effect of Medium pH on In Vitro Dissolution of Marketed Tetracyclines (Tetracycline and Doxycycline) Solid Oral Dosage Forms in Bahia, Brazil

2020 ◽  
Vol 27 (2) ◽  
pp. 32-40
Author(s):  
João Luis S. de Oliveira ◽  
Gilmar A. C. Teles Júnior ◽  
Desirée A. Bonfim ◽  
Carlos Magno R. Carvalho Júnior ◽  
Jéssica A. Santos ◽  
...  
Keyword(s):  
Dosage Forms ◽  
Oral Dosage ◽  
In Vitro Dissolution ◽  
Medium Ph ◽  
Solid Oral Dosage Forms ◽  
Oral Dosage Forms
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