Transcription of ICH Topic Q 1 A Stability Testing Guidelines: …
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ICH Topic Q 1 A Stability Testing Guidelines: …
The European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Unit CPMP/ICH/380/95. ICH Topic Q 1 A. Stability Testing guidelines : Stability Testing of New Drug Substances and Products Step 5. NOTE FOR GUIDANCE ON Stability Testing : Stability . Testing OF NEW DRUG SUBSTANCES AND PRODUCTS. (CPMP/ICH/380/95). [This guideline replaces relevant section of previous guideline]. APPROVAL BY CPMP December 1993. STUDIES CAN BE SUBMITTED ACCORDING TO THIS GUIDELINE January 1994. DATE FOR COMING INTO OPERATION 1 January 1998. (DOSSIERS SUBMITTED AFTER). ICH - Technical Coordination - R. Bass 7 Westferry Circus, Canary Wharf, London E14 4HB, UK. Tel: (+44-171) 418 84 11 Fax: (+44-171) 418 85 51. E_Mail: Stability Testing OF NEW DRUG SUBSTANCES. AND PRODUCTS. ICH Harmonised Tripartite Guideline [EMEA Status as of December 1993]. Preamble The following guideline sets out the Stability Testing requirement for a Registration Application within the three areas of the EC, Japan and the USA.
CPMP/ICH/380/95 4/13 Evaluation The design of the stability study is to establish, based on testing a minimum of three batches of the drug substance and evaluating the stability information (covering as necessary the
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