Transcription of ICH guideline Q11 on development and manufacture of drug ...
{{id}} {{{paragraph}}}
Example: barber
ICH guideline Q11 on development and manufacture of drug ...
7 Westferry Circus Canary Wharf London E14 4HB United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website An agency of the European Union European Medicines Agency, 2011. Reproduction is authorised provided the source is acknowledged. May 2011 EMA/CHMP/ICH/425213/2011 ICH/ Committee for medicinal products for human use (CHMP) ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) Step 3 Transmission to CHMP May 2011 Adoption by CHMP for release for consultation May 2011 End of consultation (deadline for comments) September 2011 Comments should be provided using this template. The completed comments form should be sent to ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) EMA/CHMP/ICH/425213/2011 Page 2/27 ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) Table of contents 1.
The intended quality of the drug substance should be determined through consideration of its use in the drug product as well as from knowledge and understanding of its physical, chemical, biological, and microbiological properties or characteristics, which can influence the development of the drug product
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: