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  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Waivers for Bioavailability and Bioequivalence Studies

    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 requirements for immediate release (IR) solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). The guidance, finalized from a 2015 draft, explains what is necessary for sponsors of investigational new drugs (INDs) and applicants of new drug ...
  • Feature ArticlesFeature Articles

    Bioequivalence Studies of Solid Oral Dosage Forms Overview

    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. Introduction 'Generic' drugs offer a significant cost saving and are ...
  • Regulatory NewsRegulatory News

    Health Canada Updates Bioavailability Requirements for Highly Variable Drugs

    Health Canada on Monday unveiled new comparative bioavailability requirements for drugs exhibiting large pharmacokinetic within-subject variation in terms of absorption. Although highly variable drugs are generally safe, the Canadian regulator says, the bioequivalence of their formulations is a problem because high variability means that large numbers of subjects are required to give adequate statistical power. In addition, highly variable drugs are poor quality formul...
  • Regulatory NewsRegulatory News

    Anvisa Updates BA, BE Test Best Practices Certification

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies.  The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharma...
  • Regulatory NewsRegulatory News

    Brazil Update: New Pharmacopeial Methods, Microbiology Testing Standards

    This content is provided by RegLink Associates . Read all of their Breaking News alerts on their website. Anvisa Proposes Alternative Pharmacopeial Methods Brazil’s national regulatory agency, Anvisa, is inviting comments on proposed alternative Pharmacopeial microbiological methods that can be used to replace those currently listed in the Brazilian Pharmacopoeia, with faster and better results.  The proposal complements the framework of documents t...
  • Regulatory Explainer: FDA Clarifies Bioequivalence, Bioavailability Approaches for Innovative Drugs

    The US Food and Drug Administration (FDA) has published a new draft guidance recommending various approaches when conducting bioequivalence (BE) and bioavailability (BA) studies in support of new and investigational drug applications. What Does FDA Mean by BA/BE? BA refers to the extent to which a drug is absorbed into the body and is thus available to act upon the drug's intended target, also known as the "site of action" (21 CFR 320.1[a]). For example, if a drug is in...
  • India’s CDSCO Says Bioequivalence Testing Centers Require Approval

    India's Central Drugs Standard Control Organization (CDSCO) issued a "clarification" to local authorities that laboratories intending to engage in bioequivalence and bioavailability (BA/BE) testing must first obtain the approval of the CDSCO before engaging in such activities.  In the clarification, the CDSCO notes that BA/BE study results will only be recognized if they are conducted by approved facilities.  Moreover, the same approval requirement extends t...
  • Health Canada Proposes Waiver for Bioavailability Studies

    Health Canada has released a new draft guidance  document proposing to allow the waiver of bioavailability studies in support of marketing authorization applications for immediate-release, solid oral dosage form drug products.  The proposed waiver would be allowed for generics, bridging studies where the formulation is different from that used in pivotal clinical trials, post-approval changes and product line extensions. Waivers would also be granted for...
  • Report: Lobbying Pushes Bioavailability Testing Provisions Into House User Fee Bill

    • 30 May 2012
    • By
    A well-connected pharmaceutical company has succeeded in inserting a provision into the House's marked-up version of pending user fee legislation to require some fees go toward research to determine whether a generic is as safe and effective as the product to which it is compared, reports The New York Times . The Times reports Endo Pharmaceuticals, soon to be renamed Endo health Solutions, hired a former Congressman and a former House staff member to lobby members of ...
  • FDA Issues Draft Guidance on Inclusion of Nanomaterials in Cosmetic Products

    • 20 April 2012
    • By
    The US Food and Drug Administration (FDA) has issued new draft guidance pertaining to the inclusion of nanomaterials in cosmetic products. The draft guidance, Safety of Nanomaterials in Cosmetic Products, was released 20 April and discusses the FDA's current thinking on the safety assessment of nanomaterials when used in cosmetic products. "Nanotechnology is an evolving technology that allows scientists to create, explore, and manipulate materials on a scale measured ...