TY - BOOK AU - Chen,Jie AU - Heyse,Joseph F. AU - Lai,Tze Leung TI - Medical product safety evaluation: biological models and statistical methods T2 - Chapman & Hall/CRC biostatistics series SN - 9781466508088 PY - 2019///. KW - Drug Evaluation KW - Methods KW - Safety KW - Clinical Trials as Topic. KW - Models, Statistical. KW - Models, Biological. N1 - '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 ER -