ICH Guideline Q11--Development and manufacture of drug substances (chemical entities and biotechnological/biological entities)," in Proceedings of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2012....
ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological/biological entities) 的准备和组织。此指南不适用于新药物开发阶段的临床研究状态的注册递交的内容。然而此指南中的开发原则对于在临床研究阶段的新药开发是重要的。 Regional requirements for post-approval ch...
ICH Q11中文版
(*)***8416E-mailich@ema.europa.euWebsite.ema.europa.euAnagencyoftheEuropeanUnion©EuropeanMedicinesAgency,2011.Reproductionisauthorisedprovidedthesourceisacknowledged.---精品文档---仅供参考学习第2页ICHguidelineQ11ondevelopmentandmanufactureofdrugsubstances(chemicalentitiesandbiotechnological/biologicalentities)...
[技术帖]ICHQ11新问答发布:起始物料选择和论证 Your Preferred Partner to Compliance The ICH Q11 Guideline describes approaches to developing and understanding the manufacturing process of drug substances. It was finalised in May 2012 and since then the pharmaceutical industry and the drug substance manufa...
内容提示: GMP 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) ICH 指导原则 Q11 原料药的开发和生产(化学实体和生物技术/生物...
OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL/BIOLOGICAL ENTITIES) Q11 Current Step 4 version dated 1 May 2012 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process...
ANNEX: QAS LINKED TO THE RESPECTIVE S CTIONS OF ICH Q11 GUIDELIN 18 iii 13 October 2016 Q11 QAs 1 PREFAC 2 Since the ICH Q11 guideline was finalised, worldwide experience with implementation of the recommendations on the development and manufacture 3 of drug substances has given rise to ...
ICH_Q11_原料药开发与制造-中英对照
1/50INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEDEVELOPMENTANDMANUFACTUREOFDRUGSUBSTANCES(CHEMICALENTITIESANDBIOTECHNOLOGICAL/BIOLOGICALENTITIES)Q11CurrentStep4versiondated1May20122/50ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWor...