Encyclopedia of biopharmaceutical statistics
著者
書誌事項
Encyclopedia of biopharmaceutical statistics
Marcel Dekker, c2000
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注記
Includes index
内容説明・目次
内容説明
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.
目次
- 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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