March 5, 2001

Briefing Information

Cover Letter

List of References

  1. Guidance for Reviewers, Potency Limits for Standardized Dust Mite and Grass Allergen Vaccines: a Revised Protocol, DHHS, FDA, CBER, November 2000    pdf    html
  2. Guidance for Industry, Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts, DHHS, FDA, CBER, November 2000,    pdf   html
  3. Notice to Readers: Public Health Service Recommendations for the Use of Vaccines Manufactured with Bovine-Derived Materials, MMWR 49:113, 2000   html
  4. Bovine Spongiform Encephalopathy  (BSE)  html
  5. 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.
  6. 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