(CHMP) Imatinib hard capsules 50 and 100 mg, film-coated tablets 100 and 400 mg product-specific bioequivalence guidance* Draft agreed by Pharmacokinetics Working Party (PKWP) October 2013 Adoption by CHMP for release for consultation 24 October 2013 Start of public consultation 15 November 2013 ...
2010年,《Guidance on the Investigation of Bioequivalence》( 生物等效性研究指导原则) 对既往指导原则做了修订,并明确规定HVD定义、试验设计、数据分析和BEL放宽标准等。 2014 年,《Compilation of Individual Product-Specific Guidance on Demonstration of Bioequivalence》( 特定药品生物等效性指南原则) 对特定药物( ...
Specific guidance isprovided: 本指南适用于应用于局部皮肤并发挥局部作用药物,也适用于其他药物,例如眼用药物与耳用药物。具体内容包括:On the quality of topical products not covered by otherguidelines. 其他指南未涵盖的外用制剂的质量。 On equivalence testing of topical products in lieu of therapeutic ...
2010年,《Guidance on the Investigation of Bioequivalence》( 生物等效性研究指导原则) 对既往指导原则做了修订,并明确规定HVD定义、试验设计、数据分析和BEL放宽标准等。 2014 年,《Compilation of Individual Product-Specific Guidance on Demonstration of Bioequivalence》( 特定药品生物等效性指南原则) 对特定药物( ...
EMA Releases API Bioequivalence Studies Guidance
In case of a multi-analyte study and specific for bioequivalence studies, attention should be paid to stability of the analytes in the matrix containing all the analytes. Sufficient attention should be paid to the stability of the analyte in the sampled matrix directly after blood sampling of ...
01 September 2013 Keywords Follicle stimulating hormone (FSH), similar biological products, comparability, non-clinical studies, clinical studies 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +...
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需要金币:*** 金币(10金币=人民币1元) EMA 关于临床试验的化学药和制剂的质量证明文件 2017.9.20 英文.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 20 September 2017 EMA/CHMP/QWP/545525/2017 Committee for Medicinal Products for Human Use (CHMP) Guideline on the requirements ...
21 May 2015 EMA/CHMP/315234/2014 Committee for Medicinal Products for Human Use (CHMP) Tadalafil film-coated tablets 2.5, 5, 10 and 20 mg product-specific bioequivalence guidance* Draft agreed by Pharmacokinetics Working Party (PKWP) October 2013 Adoption by CHMP for release for consultation 24...