principles of good laboratory practice
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL http://eur-lex.europa.eu/en/repert/1530.htm DIRECTIVE 2004/10/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances L 50/54-59 EN Official Journal of the European Union 20.2.2004 http://eur-lex.europa.eu/JOYear.do?year=2004 DIRECTIVE 2004/9/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) L 50/28 EN Official Journal of the European Union 20.2.2004 http://eur-lex.europa.eu/JOYear.do?year=2004 COMMISSION DIRECTIVE 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use L 262/22 EN Official Journal of the European Union 14.10.2003 http://eur-lex.europa.eu/JOYear.do?year=2003 ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (OECD) www.oecd.org/ehs/ OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring http://www.oecd.org/document/63/0,3746,en_2649_34365_2346175_1_1_1_1,00.html ENV/MC/CHEM(98)17 Number 1 OECD Principles on Good Laboratory Practice (as revised in 1997) http://www.oecd.org/officialdocuments/displaydocumentpdf/?cote=env/mc/chem(98)17&doclanguage=en FOOD AND DRUG ADMINISTRATION (FDA) Guidance for Industry “Bioanalytical Method Validation” May, 2001 http://www.fda.gov/cvm http://www.fda.gov/cder/guidance/index.htm#Generics U.S. Department of Health and Human Services FDA; Center for Drug Evaluation and Research (CDER); Center for Veterinary Medicine (CVM) FDA «Guidance for Industry. Bioequivalence guidance» (2006). U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine (CVM) November 8, 2006 http://www.fda.gov/.../GuidanceforIndustry/ucm052363.pdf FDA Orange Book: APPROVED DRUG PRODUCTS 26 Edition (December 31, 2005) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF PHARMACEUTICAL SCIENCE OFFICE OF GENERIC DRUGS. FDA/CDER Orange Book StaffOffice of Generic Drugs, HFD-6107500 Standish Place Rockville, MD 20855-2773 http://www.fda.gov/cder/orange/patex.htm Orange Book CUMULATIVE SUPPLEMENT 6 June 2006 Prepared By Office of Generic Drugs Center for Drug Evaluation and Research Food and Drug Administration http://www.accessdata.fda.gov/scripts/cder/ob/docs/pattermsall.cfm http://www.fda.gov/orphan/designat/list.htm THE EUROPEAN MEDICINES AGENCY FOR (EMA) http://www.ema.europa.eu GUIDELINE ON BIOANALYTICAL METHOD VALIDATION. (EMA, 2011) 21 July 2011 EMEA/CHMP/EWP/192217/2009 Committee for Medicinal Products for Human Use (CHMP) http://www.ema.europa.eu/.../2011/08/WC500109686.pdf This guideline will replace the “Note for guidance on the investigation of bioavailability and bioequivalence" CPMP/QWP/EWP/1401/98 and the related questions in the Q&A document (CHMP/EWP/40326/06). This guideline includes recommendations on BCS-based biowaivers. GUIDELINE ON VALIDATION OF BIOANALYTICAL METHODS (DRAFT) European Medicines Agency London, 19 November 2009 Doc. Ref: EMEA/CHMP/EWP/192217/2009 http://www.ema.europa.eu/docs/.../2009/12/WC500018062.pdf Good Clinical Practice compliance http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ EMA procedural advice for users of the centralised procedure for generic/hybrid applications January 2011 Doc. Ref. EMEA/CHMP/225411/2006 Committee for Human Medicinal Products (CHMP) This integrated version has been created for printing purposes only. Please refer to the individual Question & Answers as published under ‘Pre-authorisation’, ‘Regulatory’ section on the Agency’s website for access to the hyperlinked information. WORLD HEALTH ORGANIZATION (WHO) Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products»)/WHO Expert Committee on Specifications for Pharmaceutical Preparations/ WHO Technical Report Series,№ 902, 2002 http://www.who.int/medicines/publications/pharmprep/TRS_902.pdf Regulatory guidance on interchangeability for multisource (generic) pharmaceutical products WHO Technical Report Series,№ 937, 2006 Geneva, 24–28 October 2005 http://www.who.int/medicines/publications/pharmprep/TRS_937.pdf Annex 8: Proposal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate-release, solid oral dosage forms Annex 9 Additional guidance for organizations performing in vivo bioequivalence studies
