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001 ocn465378651;

003 OCoLC;

005 20141212053259.0;

008 091104s2010 nju b 001 0 eng ;

010 a| 2009045887;

015 a| GBB0494832| bnb;

016 7 a| 1015188882| DNLM;

016 7 a| 0155294252| Uk;

020 a| 9780470602256 (cloth);

020 a| 0470602252 (cloth);

029 1 a| NLMb| 101518888;

029 1 a| AU@b| 000044973590;

035 a| (Sirsi) o465378651;

035 a| (OCoLC)465378651;

042 a| pcc;

049 a| NEHH;

050 00 a| R856.4b| .A22 2010;

060 00 a| 2010 J-282;

060 10 a| W 26b| A135d 2010;

082 00 a| 610.28/40722| 22;

100 1 a| Abdel-aleem, Salah.=| ^A1020620;

245 14 a| The design and management of medical device clinical trials :b| strategies and challenges /c| Salah Abdel-aleem.;

300 a| xvii, 250 pages ;c| 25 cm;

336 a| text2| rdacontent;

337 a| unmediated2| rdamedia;

338 a| volume2| rdacarrier;

504 a| Includes bibliographical references and index.;

505 0 a| 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.;

650 0 a| Medical instruments and apparatusx| Research.=| ^A3247;

650 0 a| Clinical trials.=| ^A11330;

650 12 a| Clinical Trials as Topicx| methods.=| ^A921074;

650 12 a| Equipment and Supplies.=| ^A918810;

650 22 a| Device Approval.=| ^A941286;

994 a| C0b| TEF;

938 a| YBP Library Servicesb| YANKn| 3318157;

938 a| Coutts Information Servicesb| COUTn| 11325143;

590 a| Laupus-WCP;

598 a| NEW;

096 a| W 26 A135d 2010;

596 a| 4;

998 a| 2321054;

999 a| W 26 A135D 2010w| NLMc| 1i| 31740082675889d| 2/15/2011f| 2/15/2011g| 1l| HSLBKm| HSLp| $89.95r| Ys| Yt| HBKu| 10/18/2010x| BOOKz| HSTACKSo| .STAFF. hdjr;

The design and management of medical device clinical trials : strategies and challenges / Salah Abdel-aleem.

Author/creator	Abdel-aleem, Salah
Format	Book
Publication Info	Hoboken, N.J. : John Wiley, ©2010.
Description	xvii, 250 pages ; 25 cm
Subjects	Medical instruments and apparatus--Research. Clinical trials. Clinical Trials as Topic--methods. Equipment and Supplies. Device Approval.

Contents	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.
Local note	Laupus-WCP
Bibliography note	Includes bibliographical references and index.
LCCN	2009045887
ISBN	9780470602256 (cloth)
ISBN	0470602252 (cloth)

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Library	Location	Call Number	Status	Item Actions
Laupus	Books - Stacks	W 26 A135D 2010	✔ Available	Place Hold

The design and management of medical device clinical trials : strategies and challenges / Salah Abdel-aleem.

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