Main reason of this collection is not only to provide the regulatory Bioavailability / (in-vivo-) Bioequivalence requirement of various countries at a single location. but also to provide GCP/GLP, Australia (TGA) Australian regulatory guidelines for prescription medicines (ARGPM), European Union guidelines adopted in Australia. BA and BE: International regulatory agencies have developed recommendations and guidances for bioequivalence approaches of orally inhaled drug products (OIDPs) for local action. The objective of this article is to discuss the similarities and differences among these approaches used by international regulatory … 15.6 Choice of the reference product for bioequivalence of generic medicines 15.7 Managing dropouts in bioequivalence studies 15.8 Where to include biopharmaceutic data Contact TGA: info@tga.gov.au | 1800 020 653 | More contact info Home Safety information Consumers Health professionals Industry About the TGA News room National Center for Biotechnology Information Product-specific bioequivalence In general and unless specified otherwise or deemed not applicable in Australia, the TGA proposes to accept product specific requirements for bioequivalence demonstration described in finalised Guidelines on Product-specific bioequivalence guidance . Blood products (including biotech alternatives) It is the objective of this guidance to define, for products with a systemic effect, when bioavailability or bioequivalence studies are necessary and to formulate requirements for their design, conduct, and evaluation. The possibility of using in vitro instead of in vivo studies with pharmacokinetic end points is also envisaged. A bioequivalence study report that is submitted as a product dossier must comply with WHO guidance for bioequivalence studies and WHO Guidelines for Good Clinical Practice. Furthermore, a Bioequivalence trial information form should be completed in MS Word format for each bioequivalence study submitted within a dossier. Note for Guidance on Quality of Modified Release Products: [B: Transdermal Dosage Forms] (adopted by TGA April 2001) Effective: June 2015 Biological medicines guidelines Overarching biosimilar guidelines CHMP/437/04 Rev. 1 (pdf,120kb) Guideline on similar biological medicinal products. Replace: CHMP/437/04 (adopted by TGA 15 June 2000). bioequivalence cpmp/ewp/qwp/1401/98 rev. 1/corr **-guideline on the investigation of bioequivalence journal of bioequivalence and bioavailability, 2011, issue 3, volume 1, 016-019 for most cases, bioequivalence is concluded if 90% ci geometric mean ratios of test/reference product for cmax and auc0-t are within 80.00-125.00% bioequivalence - … The aim of the present paper is to summarize the revised European Union (EU) Guideline on the Investigation of Bioequivalence and to discuss critically with respect to previous European This guideline describes the principles of procedures of bioequivalence studies of generic products. The objective of the study is to assure therapeutic equivalence of generic products to innovator products. In the bioequivalence study, bioavailability should be compared for innovator and generic products. If this is not feasible, This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs) and ANDA supplements. This guidance provides recommendations to applicants planning to include bioequivalence (BE)