Williamson Leah N, Conner Dale P, Stier Ethan M, Davit Barbara M
US FDA, Center for Drug Evaluation & Research, Office of Generic Drugs, 11919 Rockville Pike, Rockville, MD 20852, USA.
Bioanalysis. 2014 Feb;6(4):441-5. doi: 10.4155/bio.13.329.
The US FDA published A Guidance for Industry: Bioanalytical Method Validation in May 2001. Despite the publication of the guidance, companies continue to submit bioequivalence studies with bioanalytical deficiencies that preclude Abbreviated New Drug Application approval. The Divisions of Bioequivalence in the FDA's Office of Generic Drugs conducted a survey of the bioequivalence submissions over a 10-year period (2001-2011) to identify the most commonly occurring bioanalytical deficiencies.
Data from a total of 4028 Abbreviated New Drug Application submissions were collected to identify bioanalytical deficiencies. Of the three categories of bioanalytical deficiencies (method, validation and report), the majority of the deficiencies were from the bioanalytical method validation section. Globally, the percentage of bioanalytical method validation deficiencies was 62%.
The approval of generic drugs would be accelerated if these deficiencies were avoided by generic companies by adhering to the guidance and therefore submitting a more complete application.
美国食品药品监督管理局（US FDA）于2001年5月发布了《工业指南：生物分析方法验证》。尽管发布了该指南，但各公司仍在提交存在生物分析缺陷的生物等效性研究报告，这些缺陷导致简略新药申请无法获批。FDA仿制药办公室的生物等效性部门对10年期间（2001 - 2011年）提交的生物等效性报告进行了一项调查，以确定最常见的生物分析缺陷。
共收集了4028份简略新药申请报告的数据，以识别生物分析缺陷。在生物分析缺陷的三个类别（方法、验证和报告）中，大多数缺陷来自生物分析方法验证部分。从全球范围来看，生物分析方法验证缺陷的比例为62%。
如果仿制药公司遵循该指南，避免这些缺陷，从而提交更完整的申请，那么仿制药的审批速度将会加快。
