A01=Jun Shao
A01=Shein-Chung Chow
active
Active Control Agent
Active Control Trial
Adaptive Randomization
advanced pharmaceutical data modeling
agent
assay validation methods
Author_Jun Shao
Author_Shein-Chung Chow
bioequivalence studies
Category=PBT
clinical trial design
confidence
control
Crossover Design
dissolution
Dissolution Profiles
Dissolution Testing
Drug Product
eq_isMigrated=1
eq_isMigrated=2
eq_nobargain
Estimated Power Approach
F2 Similarity Factor
FDA Stability Guideline
hypothesis
incomplete data analysis
INDIAN EDITION
Inter-reader Agreement
Intersection Union Test
interval
Medical Imaging Agent
NF Test
Permuted Block Randomization
pharmaceutical statistics
product
QOL Instrument
Reproducibility Probability
Roc Curve
Shelf Life Estimation
Test Drug Product
testing
Therapeutic Equivalence
therapeutic noninferiority analysis
Toss Procedure
Vitro Bioequivalence
Vivo Bioequivalence Testing
Product details
- ISBN 9780367396336
- Weight: 453g
- Dimensions: 156 x 234mm
- Publication Date: 05 Sep 2019
- Publisher: Taylor & Francis Ltd
- Publication City/Country: GB
- Product Form: Paperback
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Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics applications for each stage of pharmaceutical development to ensure the valid design, analysis, and assessment of drug products under investigation and establish the safety and efficacy of pharmaceutical compounds. Coverage include statistical techniques for assay validation and evaluation of drug performance characteristics, testing population/individual bioequivalence and in vitro bioequivalence according to the most recent FDA guidelines, basic considerations for the design and analysis of therapeutic equivalence and noninferiority trials.
Chow, Shein-Chung; Shao, Jun
