Design and management of medical device clinical trials :
Abdel-aleem, Salah.
Design and management of medical device clinical trials : strategies and challenges Salah Abdel-aleem. - Hoboken, N.J. : Wiley, ©2010. - xvii, 250 p. ; 25 cm.
Includes bibliographical references and index.
Challenges to the design of clinical study -- Challenges to managing the study -- Selection of historic controls -- Fraud and misconduct in clinical trials -- Challenges to the regulation of medical device -- Challenges of global clinical studies and the CE mark process -- Challenging FDA PMA cases -- Bioethics in clinincal research.
9780470602256
2009045887
GBB049483 bnb
101518888 DNLM 015529425 Uk
Medical instruments and apparatus--Research.
Clinical trials.
Clinical Trials as Topic--methods.
Equipment and Supplies.
Device Approval.
R856.4 / .A22 2010
610.28 / ABD-D
2010 J-282 W 26 / A135d 2010
Design and management of medical device clinical trials : strategies and challenges Salah Abdel-aleem. - Hoboken, N.J. : Wiley, ©2010. - xvii, 250 p. ; 25 cm.
Includes bibliographical references and index.
Challenges to the design of clinical study -- Challenges to managing the study -- Selection of historic controls -- Fraud and misconduct in clinical trials -- Challenges to the regulation of medical device -- Challenges of global clinical studies and the CE mark process -- Challenging FDA PMA cases -- Bioethics in clinincal research.
9780470602256
2009045887
GBB049483 bnb
101518888 DNLM 015529425 Uk
Medical instruments and apparatus--Research.
Clinical trials.
Clinical Trials as Topic--methods.
Equipment and Supplies.
Device Approval.
R856.4 / .A22 2010
610.28 / ABD-D
2010 J-282 W 26 / A135d 2010