Equilab International laboratory is an independent and the first ISO/IEC 17025 accredited laboratory in Indonesia for providing services to pharmaceutical industries in bioavailability/bioequivalence studies.
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
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