你们随后报告了合格的复测结果。 For example, during your analytical method verification for residual solvent for(b)(4)API, your firm initiated numerous LI concerning failures of the test's accuracy, method precision, or intermediate precision parameters...
2019年FDA CDER抗感染产品部门的Ramya Gopinath博士在FDA Clinical Investigator Course培训中分享了《Safety Considerations in Phase Ⅰ Trials》,其中关于最大剂量设定的建议如下图所示,与EMA的观点基本上是一致的。不过,从EMA和FDA的表述中,能看到同一个关键词“target saturation”,两地监管机构均将这一PD指标在最...
See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download. 请参阅FDA的指南《工艺验证:一般...
美国FDA 指导原则 上市后研究和临床试验--联邦食品、药品和化妆品法工业指南草案第505(O)(3)节的实施 英文原版.pdf,Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act Guidance for Industry
美国FDA 指导原则 临床研究人员不当行为后临床封存的使用 英文原版.pdf,Guidance for Industry and Clinical Investigators The Use of Clinical Holds Following Clinical Investigator Misconduct U.S. Department of Health and Human Services Food and Drug Administr
This guidance provides recommendations to sponsors of drugs or biologics for the treatment of cancer regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master...
“specific investigational product orproduct-derivation strategyto evaluate in a clinical study before requesting an INTERACT meeting” (emphasis added). In contrast to the scope for INTERACT meetings, the draft guidance describes an example of when a pre-IND meeting would be appropriate as being ...
During our inspection, our investigator observed specific violations including, but not limited to, the following. 在我们的检查过程中,调查员发现了具体的违规行为,包括但不限于以下行为。 设备问题 1. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug product...
Will the new FDA guidance impact Satellite Investigator Centres?doi:10.1002/qaj.450ColinGlobalWilsherGlobalWileyThe Quality Assurance Journal
Will the new FDA guidance impact Satellite Investigator Centres?No abstract is available for this article.doi:10.1002/qaj.450Colin WilsherJohn Wiley & Sons, Ltd.The Quality Assurance Journal