Asean guideline on stability study of drug
Found 5 free book(s)
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG …
www.hsa.gov.sg5th Draft ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT Version 6.0 Update revision : May 2013 Document Control Version Date 1.0 July 2004 (8th ACSQ PPWG Meeting; Bangkok)
ASEAN GUIDELINE ON STABILITY STUDY OF DRUG …
www.pharmalytik.com1 ASEAN GUIDELINE ON STABILITY STUDY OF DRUG PRODUCT Version 4.0 Update revision : May 2012 Document Control Version Date 1.0 thJuly 2004 (8 ACSQ PPWG Meeting; Bangkok)
ICH Q5C Stability testing of Biotechnological / …
www.ich.org4 ICH Q5C - Stability testing of Biotechnological / Biological products ICH guidelines on stability • Q1A - Stability testing for new drug substances and products (R2 - 2003)
BIOFARMA EXPERIENCE WITH ASEAN CTD - …
www.dcvmn.org•Established in Jakarta (ASEAN Secretariat), December 2016 • Guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier
Stability Testing of Pharmaceutical Products in a …
www.who.intRegulatory Feature The ASEAN developments meant a decision would have to be made on whether to amend the WHO guidance A decision was eventually taken to split