• 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

    EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form

    The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA). The update, drafted in July 2015 , comes as there has been an increasing trend toward the outsourcing of manufacturing and more complex supply chains. The guideline "does not introduce new requirements" on authorized drugs, though t...
  • Feature ArticlesFeature Articles

    FDA Inspections and Outcomes for Oral Solid Dosage (OSD) Manufacturing Facilities

    The article discusses various types of current Good Manufacturing Practice (CGMP) inspections conducted by the US Food and Drug Administration (FDA) at oral solid dosage forms manufacturing facilities. It also elaborates on types of inspections, approaches to investigations, limitations of these inspections and major inspection outcomes in the event of deficiencies, including 483s, Warning Letters and Establishment Investigation Reports (EIRs). Introduction Civil and ...
  • Regulatory NewsRegulatory News

    FDA Adopts, Releases ICH Document on Dose Uniformity

    The US Food and Drug Administration (FDA) has adopted and released a new guidance document intended to clarify the International Conference on Harmonisation's (ICH) Q4B guideline on the use of pharmacopoeial texts. Background ICH is a regional harmonization group composed of the US, EU and Japan, as well as other countries which serve in a voluntary capacity. The aim of the group is to allow the regulatory processes of each to better align with those of the others,...