ALLERGENIC PRODUCTS ADVISORY COMMITTEE
March 5, 2001
Briefing Information
Cover Letter
List of References
- Guidance for Reviewers, Potency Limits for Standardized Dust Mite and
Grass Allergen Vaccines: a Revised Protocol, DHHS, FDA, CBER, November
2000 pdf
html
Guidance for Industry, Testing Limits in Stability Protocols for
Standardized Grass Pollen Extracts, DHHS, FDA, CBER, November
2000, pdf
html
Notice to Readers: Public Health Service Recommendations for the Use of
Vaccines Manufactured with Bovine-Derived Materials, MMWR 49:113,
2000 html
Bovine Spongiform Encephalopathy (BSE) html
Schuimann DJ, Pharmacometrics: A Comparison of the Two One-Sided Tests
Procedure and the Power of Approach for Assessing the Equivalence of Average
Bioavailablility, J. Pharmacokinetics Biopharmaceutics, 15(6):657-680, 1987.
Statistical Principles for Clinical Trials, ICH Harmonized Tripartite
Guideline (step 4 of the ICH Process at the ICH Steering Committee meeting on
5 February 1998, recommended for adoption, ICH E9, at pdf