良好实验室规范的原则
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL http://eur-lex.europa.eu/en/repert/1530.htm DIRECTIVE 2004/10/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 二月 2004 关于法律的统一, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances L 50/54-59 CN 欧盟官方公报 20.2.2004 http://eur-lex.europa.eu/JOYear.do?year=2004 DIRECTIVE 2004/9/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 二月 2004 关于良好实验室规范的检查和验证 (良好实验室规范) L 50/28 CN 欧盟官方公报 20.2.2004 http://eur-lex.europa.eu/JOYear.do?year=2004 COMMISSION DIRECTIVE 2003/94/EC of 8 十月 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use L 262/22 CN 欧盟官方公报 14.10.2003 http://eur-lex.europa.eu/JOYear.do?year=2003 ORGANISATION FOR ECONOMIC CO-OPERATION AND DEVELOPMENT (经合组织) www.oecd.org/ehs/ OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring http://www.oecd.org/document/63/0,3746,en_2649_34365_2346175_1_1_1_1,00.html ENV/MC/CHEM(98)17 数字 1 经合组织良好实验室规范原则 (修订于 1997) http://www.oecd.org/officialdocuments/displaydocumentpdf/?科特迪瓦=env/mc/chem(98)17&doclanguage=en FOOD AND DRUG ADMINISTRATION (美国食品药品监督管理局) Guidance for Industry “Bioanalytical Method Validation” May, 2001 http://www.fda.gov/cvm http://www.fda.gov/cder/guidance/index.htm#Generics U.S. 卫生与公众服务部 FDA; 药物评价研究中心 (CDR); 兽医中心 (CVM) FDA «行业指南. 生物等效性指南» (2006). 我们. 卫生与公众服务部食品药品监督管理局兽医中心 (CVM) 十一月 8, 2006 http://www.fda.gov/.../GuidanceforIndustry/ucm052363.pdf FDA Orange Book: 批准的药品 26 版 (十二月 31, 2005) U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH OFFICE OF PHARMACEUTICAL SCIENCE OFFICE OF GENERIC DRUGS. FDA/CDER 橙皮书工作人员仿制药办公室, HFD-6107500 罗克维尔斯坦迪什广场, 医学博士 20855-2773 http://www.fda.gov/cder/orange/patex.htm Orange Book CUMULATIVE SUPPLEMENT 6 六月 2006 Prepared By Office of Generic Drugs Center for Drug Evaluation and Research Food and Drug Administration http://www.accessdata.fda.gov/scripts/cder/ob/docs/pattermsall.cfm http://www.fda.gov/orphan/designat/list.htm THE EUROPEAN MEDICINES AGENCY FOR (EMA) http://www.ema.europa.eu GUIDELINE ON BIOANALYTICAL METHOD VALIDATION. (EMA, 2011) 21 七月 2011 EMEA/CHMP/EWP/192217/2009 Committee for Medicinal Products for Human Use (人类健康管理计划) http://www.ema.europa.eu/.../2011/08/WC500109686.pdf This guideline will replace the “Note for guidance on the investigation of bioavailability and bioequivalence" CPMP/QWP/EWP/1401/98 以及 Q 中的相关问题&一份文件 (CHMP/EWP/40326/06). 该指南包括关于基于 BCS 的生物豁免的建议. 生物分析方法验证指南 (草稿) European Medicines Agency London, 19 十一月 2009 医生. 参考号: EMEA/CHMP/EWP/192217/2009 http://www.ema.europa.eu/docs/.../2009/12/WC500018062.pdf Good Clinical Practice compliance http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ EMA procedural advice for users of the centralised procedure for generic/hybrid applications January 2011 医生. 参考号. EMEA/CHMP/225411/2006 Committee for Human Medicinal Products (人类健康管理计划) 该集成版本仅用于打印目的. 请参阅个别问题 & 在“预授权”下发布的答案, 该机构网站上的“监管”部分用于访问超链接信息. 世界卫生组织 (WHO) 用于可互换多源等效性评估的对照药品选择指南 (通用的) 产品”)/WHO Expert Committee on Specifications for Pharmaceutical Preparations/ WHO Technical Report Series,○ 902, 2002 http://www.who.int/medicines/publications/pharmprep/TRS_902.pdf Regulatory guidance on interchangeability for multisource (通用的) pharmaceutical products WHO Technical Report Series,○ 937, 2006 日内瓦, 24– 10 月 28 日 2005 http://www.who.int/medicines/publications/pharmprep/TRS_937.pdf Annex 8: 关于放弃世卫组织基本药物速释标准清单体内生物等效性要求的提案, solid oral dosage forms Annex 9 对进行体内生物等效性研究的组织的额外指导
有兴趣了解当前的临床计划是否, 研究进展, 或新兴的治疗方法可能与您的情况相关?
仅教育和研究信息. 个人医疗决定应咨询合格的医疗保健专业人员.
