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Quality and Ethics Standard


 

 

Good Laboratory Practice Principles
(ISO/IEC 17025)/GLP General requirements for the competence of testing and  calibration laboratories, 2005.
 
 
ASEAN Guideline for Bioequivalence Study, 2004.  
Guideline for Bioequivalence Study in Indonesia, The National Agency of Drug and Food Control, 2004.

Guideline for Good Clinical Practice in Indonesia, The National Agency of Drug and Food Control, 2001.
 
The International Conference on Harmonization (ICH) Harmonized Tripartite: Guideline for Clinical Practice (E6-R1), June 1996.    
Guidance for Industry Bio Analytical Method Validation, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), May 2001.    
World Medical Association Declaration Of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, 2004.