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

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