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美国FDA关于口服固体制剂BA与BE的指导原则
Guidance for Industry
Bioavailability and Bioequivalence
Studies for Orally Administered
Drug Products — General
Considerations
DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Comments and suggestions regarding this draft document should be submitted within 30 days of
publication in the Federal Register of the notice announcing the availability of the draft
guidance. Submit comments to Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be
identified with the docket number listed in the notice of availability that publishes in the Federal
Register .
For questions regarding this draft document contact (CDER) Aida Sanchez 301-827-5847.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
July 2002
BP
J:\!GUIDANC\4964dft.doc
07/10/02
Guidance for Industry
Bioavailability and Bioequivalence
Studies for Orally Administered
Drug Products — General
Considerations
Additional copies are available from:
Office of Training and Communication
Division of Drug Information, HFD-240
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
(Tel) 301-827-4573
/cder/guidance/index.htm
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