Results 151 to 160 of about 781 (182)

Impact of Biopharmaceutics Classification System-Based Biowaivers

Molecular Pharmaceutics, 2010
The Biopharmaceutics Classification System (BCS) is employed to waive in vivo bioequivalence testing (i.e. provide "biowaivers") for new and generic drugs that are BCS class I. Granting biowaivers under systems such as the BCS eliminates unnecessary drug exposures to healthy subjects and provides economic relief, while maintaining the high public ...
Jack A, Cook, Barbara M, Davit, James E, Polli   +2 more
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Biowaivers for Oral Immediate-Release Products

Clinical Pharmacokinetics, 2004
Bioequivalence of drug formulations plays an important role in drug development. Recently, the Biopharmaceutical Classification System (BCS) has been implemented for the purpose of waiving bioequivalence studies on the basis of the solubility and gastrointestinal permeability of drug substance.
Fried, Faassen, Herman, Vromans
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Biowaiver and Biopharmaceutics Classification System

2014
Biowaiver is defined as FDA waiving the requirement for the in vivo bioavailability/bioequivalence studies. This chapter discusses the following biowaivers: (a) For drug products where bioavailability is self-evident e.g., solutions, (b) Biowaivers in situations where one can rely on in vitro methods instead of in vivo for assessing bioavailability ...
Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, Lawrence X. Yu   +3 more
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Biowaiver or Bioequivalence: Ambiguity in Sildenafil Citrate BCS Classification

AAPS PharmSciTech, 2018
The aim of the present study is to contribute to the scientific characterization of sildenafil citrate according to the Biopharmaceutics Classification System, following the World Health Organization (WHO) guidelines for biowaivers. The solubility and intestinal permeability data of sildenafil citrate were collected from literature; however, the ...
Claudia Miranda, Zenia Pérez-Rodríguez, Rosario Hernández-Armengol, Yaidel Quiñones-García, Tania Betancourt-Purón, Miguel Ángel Cabrera-Pérez   +5 more
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Implementing the additional strength biowaiver for generics: EMA recommended approaches and challenges for a US-FDA submission

European Journal of Pharmaceutical Sciences, 2018
International audienceThis review describes the EMA requirements on biowaivers for additional strengths of immediate release and modified release oral solid dosage forms focused on generic applications and highlights the challenges for a simultaneous EMA
Paulo Paixão, jean-michel CARDOT
exaly   +2 more sources

The Gradually Expanding Scope for Biowaivers of Oral Products: An Overview

Current Pharmaceutical Design, 2017
The regulatory paradigm is relaxing gradually without compromising the safety, efficacy and the quality of the drug product and, most importantly, a perceptible scientific consensus is maturing towards the need of affordable medicines. The establishment of bioequivalence (BE) is no longer being considered to be accomplished only by in vivo studies in ...
Vikrant, Saluja, Amanpreet, Singh, Adnan M, Algradi   +2 more
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Biowaiving Based on the BCS—A Global Comparison

2016
INTRODUCTION Introduction of the Biopharmaceutics Classification System (BCS) (see chap. 8) was intended to reduce in vivo bioequivalence studies, in particular for applications of generic drug products. Actually, in its simplifications, the BCS concept addresses the complex question of what affects drug substance bioavailability and when formulation ...
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Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine

Journal of Pharmaceutical Sciences, 2015
Literature data relevant to the biopharmaceutical properties of the active pharmaceutical ingredient (API) nifedipine are reviewed to evaluate whether a waiver of in vivo bioequivalence (BE) testing of immediate-release (IR) dosage forms formulated as tablets and soft gelatin capsules is warranted.
Gajendran, J, Kramer, J, Shah, VP, Langguth, P, Polli, J, Mehta, M, Groot, DW, Cristofoletti, R, Abrahamsson, B, Dressman, JB   +9 more
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Biowaiver monographs for immediate-release solid oral dosage forms: Lemborexant

Journal of Pharmaceutical Sciences
Lemborexant is a dual orexin receptor antagonist assigned to class II of the Biopharmaceutics Classification System (BCS). Thus, the ICH M9 Guideline excludes immediate-release (IR) solid oral dosage forms containing lemborexant from BCS-based biowaivers, irrespective of their in vitro dissolution behavior.
Beran, Kristian, Abrahamsson, Bertil, Charoo, Naseem, Cristofoletti, Rodrigo, Holm, René, Kambayashi, Atsushi, Langguth, Peter, Mehta, Mehul, Parr, Alan, Polli, James E., Shah, Vinod P., Dressman, Jennifer   +11 more
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Biowaiver studies of newly optimized meloxicam tablets

Pakistan Journal of Pharmaceutical Sciences, 2018
In this research work biowaiver studies of newly developed and optimized Meloxicam 7.5mg and 15mg water dispersible formulations were carried out at different dissolution media i.e. 0.1N HCl, phosphate buffer pH 4.5, pH 6.8, and pH 7.5 at 50 rpm. For this purpose reference (MA9 and MB9) and tests (MA2, MA4, MA6, MA7 and MA8 (15 mg) and MB2, MB4, MB6 ...
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