Chen, Jie,

Medical product safety evaluation : biological models and statistical methods / Jie Chen, Joseph F. Heyse, Tze Leung Lai. - xviii, 353 pages : illustrations; 24cm. - Chapman & Hall/CRC biostatistics series . - Chapman & Hall/CRC biostatistics series .

'A Chapman & Hall book.'

Includes bibliographical references and index.

Biological models and associated statistical methods -- Benefit-risk -- Design and analysis of clinical trials with safety endpoints -- Multiplicity in the evaluation of clinical safety data -- Causal inference from post-marketing data -- Safety databases : statistical analysis and pharmacovigilance -- Sequential methods for safety surveillance.

9781466508088 RM444.91


Drug Evaluation--Methods.
Safety.
Clinical Trials as Topic.
Models, Statistical.
Models, Biological.