Search Results for bioavailability

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FDA Finalizes Guidance on Waivers for Bioavailability and Bioequivalence Studies By Zachary Brennan - Published 22 December 2017

The US Food and Drug Administration (FDA) on Friday finalized guidance for sponsors who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study for immediate release (IR) solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS).

Categories: News, US, FDA, Drugs, Due Diligence, Research and development

Tags: bioavailability, bioequivalence, BCS

Bioequivalence Studies of Solid Oral Dosage Forms Overview By Sharry Arora - Published 16 August 2017

The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.

Categories: Features, EMA, FDA, Health Canada, MHLW, PMDA, TGA, WHO, Generic drugs

Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability

Health Canada Updates Bioavailability Requirements for Highly Variable Drugs By Zachary Brennan - Published 18 April 2016

Health Canada on Monday unveiled new comparative bioavailability requirements for drugs exhibiting large pharmacokinetic within-subject variation in terms of absorption.

Categories: News, Canada, Health Canada, Clinical, Drugs, Research and development

Tags: Health Canada, bioequivalence, highly variable drug products, bioavailability, pharmacokinetic

Anvisa Updates BA, BE Test Best Practices Certification By Louise Zornoza, RegLink News - Published 10 October 2014

Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies. 

Categories: News, Latin America and Caribbean, Anvisa, Compliance, Generic drugs

Tags: BA, BE, Bioavailability, Bioequivalence, Certification of Good Practice

Brazil Update: New Pharmacopeial Methods, Microbiology Testing Standards By Louise Zornoza, RegLink - Published 14 July 2014

Updates on the regulation of pharmaceutical products in Brazil.

Categories: News, Latin America and Caribbean, Anvisa, Drugs

Tags: Brazil, Pharmacopeia, Bioequivalence, Bioavailability

Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs By Alexander Gaffney, RAC - Published 17 March 2014

Categories: US, FDA

Tags: NDA Supplement, BA/BE, Regulatory Explainer, BA, Bioavailability, BE, IND, Latest News, pharmaceutical, bioequivalence, draft guidance, NDA

India’s CDSCO Says Bioequivalence Testing Centers Require Approval By Louise Zornoza, RegLink - Published 09 January 2014

Categories: Regulatory Update, India, CDSCO

Tags: BA, Bioavailability, BE, bioequivalence

Health Canada Proposes Waiver for Bioavailability Studies By Louise Zornoza, RegLink - Published 22 August 2012

Categories: Health Canada

Tags: Biowaiver, Bioavailability, Latest News, draft guidance

Report: Lobbying Pushes Bioavailability Testing Provisions Into House User Fee Bill By Alexander Gaffney - Published 30 May 2012

Tags: Lidoderm, Bioequivalency, FDARA, Endo Pharmaceuticals, Bioavailability, Competition, Generic, Latest News, GDUFA, PDUFA

FDA Issues Draft Guidance on Inclusion of Nanomaterials in Cosmetic Products By Alexander Gaffney - Published 20 April 2012

Tags: Bioavailability, Nano, Toxicology, Cosmetic, nanomaterials, Latest News, testing, safety