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Encyclopedia Of Biopharma- Ceutical Statistics

Encyclopedia Of Biopharma- Ceutical Statistics


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About the Book

This encyclopaedia covers all topics in biopharmaceutical evaluation of data at critical stages in the research and development process - highlighting the vital areas of statistical design and regulatory requirements. Each entry provides self-contained, self-explanatory and accessable data to nonbiostatisticians; "real-world" examples of statistical design and practice in the pharmaceutical industry; and standards on good laboratory practice, good clinical practice, good manufacturing practice, and good statistics practice.

Table of Contents:
Adjustment for covariates; Ames test; assay development; assay validation; Bayesian statistics; bioassay; bioavailability and bioequivalence; biologics; biopharmaceutics; bracketing design; cancer trials; carcinogenicity studies; carry forward analysis; clinical endpoint; clinical pharmacology; clinical trials; clinical trial process; confounding and interaction; content uniformity; contract research organization (CRO); crossover design; cutoff design; data monitoring board (DMB); dose proportionality; dropout; drug development; enrichment design; equivalence trials; ethnic factors; extra variation models; factorial designs; food and drug administration; global database and system; good programming practice; good statistics practice; group sequential methods; individual bioequivalence; integrated bioequivalence; integrated summary report; intention-to-treat analyses; international conference on hormonization (ICH); IVRS; Lilly reference ranges; meta-analysis; mixed effects models; multicentre trials; multiple comparisons; multiple-dose bioequivalence studies; multiple endpoints; parallel designs; patient compliance; pharmacodynamic issues; pharamcodynamic with covariates; pharmacodynamic with no covariates; pharmacoeconomics; placebo effect; post marketing surveillance; power; protocol development; process validation; release targets; reproductive studies; robust analysis for cross-over design; sample size determination; screening design; specifications; stability matrix design; statistical significance; subgroup analysis; surrogate endpoint; therapeutic equivalence; titration design; USP tests.


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Product Details
  • ISBN-13: 9780824760014
  • Publisher: Taylor & Francis Inc
  • Publisher Imprint: Marcel Dekker Inc
  • Language: English
  • No of Pages: 552
  • ISBN-10: 0824760018
  • Publisher Date: 28 Jan 2000
  • Binding: Hardback
  • No of Pages: 552
  • Returnable: N


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Encyclopedia Of Biopharma- Ceutical Statistics
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