عنوان

Benefit-risk assessment in pharmaceutical research and development

شابک

1439867941

شابک

143986795X

شابک

9781439867945

شابک

9781439867952

شماره

b544221

عنوان اصلي

Benefit-risk assessment in pharmaceutical research and development

نام عام مواد

[Book]

نام نخستين پديدآور

edited by Andreas Sashegyi, Eli Lilly and Company Indianapolis, Indiana, USA, James Felli, Eli Lilly and Company Indianapolis, Indiana, USA, Rebecca Noel, Eli Lilly and Company Indianapolis, Indiana, USA.

محل نشرو پخش و غیره

Boca Raton

نام ناشر، پخش کننده و غيره

CRC Press

تاریخ نشرو بخش و غیره

[2014] ©2014

نام خاص و کميت اثر

: text file, PDF

عنوان فروست

Chapman & Hall/CRC biostatistics series.

متن يادداشت

Section 1. Early clinical development --;section 2. Full clinical development --;section 3. Regulatory review and policy --;section 4. Post-launch assessment.

متن يادداشت

This book is about benefit and risk. More precisely, this book is about the definition, assessment, balance and communication of favorable and unfavorable consequences of treatments in pharmaceutical research and development. This book is not a definitive treatise on benefit and risk in pharmaceutical research and development. It is not a prescriptive guide for characterizing the benefits and risks of a molecule under development. Nor is it a collection of best practices and recommendations for a successful benefit and risk assessment. It is a gateway. It is a gateway that opens into a long corridor that chronicles the concepts, assessment methods, interpretations and implications of benefits and risks as a molecule journeys from concept to customer. Along the corridor are four doors that open into four galleries. Depending upon our experiences and state of mind, these doors may appear dark and foreboding, etched with esoteric runes and rubbed with mystic herbs ... or curious and unusual entryways we've walked by for years yet never thought to enter ... or enticing and accessible points of access to newly revealed vistas abundant with challenge and promise. Each door in the corridor will bear one of four brass plates: Early Clinical Development, Full Clinical Development, Regulatory Review and Policy, Post Launch Assessment. In the Early Clinical Development gallery, we will encounter interpretations of benefit and risk in the context of a molecule moving from discovery through its preclinical evaluation and its initial testing in man. The Full Clinical Development door opens into a gallery that considers benefit and risk during a molecule's journey from its entry into man until it is submitted to regulators for approval--

موضوع مستند نشده

Drugs -- Testing.

موضوع مستند نشده

Health risk assessment.

موضوع مستند نشده

Pharmacoepidemiology.

شماره رده

نشانه اثر

مستند نام اشخاص تاييد نشده

edited by Andreas Sashegyi, Eli Lilly and Company Indianapolis, Indiana, USA, James Felli, Eli Lilly and Company Indianapolis, Indiana, USA, Rebecca Noel, Eli Lilly and Company Indianapolis, Indiana, USA.

مستند نام اشخاص تاييد نشده

Andreas Sashegyi

مستند نام اشخاص تاييد نشده

James Felli

مستند نام اشخاص تاييد نشده

Rebecca Noel

نام الکترونيکي

نوع ماده

[Book]

تكميل شده

Y