FDA 发布 1999 年 6 月草案指南统计信息及 1999 年 8 月 18 日发布的体外生物等效性数据统计信息（草案，不用于实施）
Statistical Information from the June 1999 Draft Guidance and Statistical Information for In Vitro Bioequivalence Data Posted on August 18, 1999
FDA 药品评价与研究中心将 1999 年 6 月草案指南中的原始统计信息与 1999 年 8 月 18 日发布的体外生物等效性数据统计信息合并发布，供业界参考。该文件为草案，不用于实施，含非约束性建议，两份材料均需更新。针对局部作用鼻用气雾剂和鼻喷雾剂生物利用度与生物等效性研究的体外非轮廓生物等效性数据统计分析方法仍在制定中，后续将纳入罐内（生命阶段间）方差分量估计。
GUIDANCE DOCUMENT
Draft
Not for implementation. Contains non-binding recommendations.
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research
Statistical analysis method recommendations for in vitro nonprofile bioequivalence data, to accompany the draft guidance for industry entitled Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (April 2, 2003), are under development. At a later time, the analysis methods will be posted. Until these methods are prepared, two documents, both in need of updating, are being made available in the present document. These documents are the original statistical information taken from the earlier June 1999 draft of this guidance, and also from the added Statistical Information for In Vitro Bioequivalence Data material posted on August 18, 1999. The subsequent implementation will include the estimation of within canister (between life stage) component of variance.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov