Archive for the 'Bioequivalence Study (BA/BE)' Category

Bioequivalence Guidelines

a. Bioequivalence Guidelines

  • Committee for Medicinal Products for Human Use (CHMP), EMEA (The European Agency for The Evaluation of Medicinal Products): Guideline on the Investigation of Bioequivalence, Jan 2010
  • EMEA (The European Medicines Agency), Procedure for Conducting GCP Inspections Requested by The EMEA: Bioanalytical Part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials (Annex VII), March 2008
  • Center for Drug Evaluation and Research (CDER), FDA: Guidance for Industry Bioavailability and Bioequivalence Studies for Orally Administered Drug Products — General Considerations, March 2003
  • WHO Technical Report Series, No. 937, 2006., Annex 9: Additional guidance for organizations performing in vivo bioequivalence studies
  • ASEAN Guidelines: “The Conduct of Bioavailability and Bioequivalence Studies”, July 2004.
  • BPOM Indonesia: “Pedoman Uji Bioekivalensi”, 2004.
  • BPOM Indonesia, Peraturan Kepala BPOM RI tahun 2011 : “Obat Wajib Uji Bioekivalensi”

b. GCP Guideline for Clinical Aspect

  • GCP ICH-E6
  • EMEA (The European Medicines Agency), Procedure for Conducting GCP Inspections Requested by The EMEA: Sponsor Site and/or CRO (Annex IV), Sept 2007
  • EMEA guidance related to the implementation of GCP_INS/GCP 1-4, and corrigendum
  • WHO Technical Report Series, No. 850, 1995, Annex 3: Guidelines for good clinical practice (GCP) for trials on pharmaceutical products
  • BPOM:“Indonesian Guideline for Good Clinical Practice”, 2006

c. GLP Guideline for Bioanalytical Aspect

  • CDER, FDA: “Guidance for Industry, Bioanalytical Method Validation”, May 2001
  • ISO 17025:2005


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