Contract Research And Development Organizations-Their History, Selection, And Utilization de Gad, Shayne C. Format Broché

Contract Research and Development Organizations-Their History, Selection, and Utilization - Gad, Shayne C.

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Brand new, In English, Fast shipping from London, UK; Tout neuf, en anglais, expédition rapide depuis Londres, Royaume-Uni;ria9783030430757_dbm

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Présentation Contract Research And Development Organizations - Their History, Selection, And Utilization de Gad, Shayne C. Format...
- Livre Médecine, Pharmacie, Paramédical, Médecine vétérinaire

Livre Médecine, Pharmacie, Paramédical, Médecine vétérinaire - Gad, Shayne C. - 30/06/2021 - Broché - Langue : Anglais

Auteur(s) : Gad, Shayne C. - Serota, David G. - Spainhour, Charles B.

Editeur : Springer International Publishing

Langue : Anglais

Parution : 30/06/2021

Format : Moyen, de 350g à 1kg

Nombre de pages : 536

Expédition : 685

Dimensions : 21.0 x 14.8 x 2.9

ISBN : 9783030430757

Résumé :

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: ? The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. ? Study directors and principal investigators. ? The nuts and bolts of study performance. ? Electronic reporting requirements ? SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). ? Consultants and their roles. ? An expanded examination of common problems and their solutions. This book boasts complete directories to the global universe of operating labs ? where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities ? and for auditing studies and projects at such facilities ? are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.

Biographie:
Dr. Shayne Gad has ?ver 43 years experience as a toxicologist, statistical consultant, manager and consultant on research and development in the chemical, consumer product, contract testing, biotechnology, medical device, and pharmaceutical industries. He is experienced in occupational and industrial toxicology, development programs (both preclinical and clinical) and study design, conduct and reporting, in evaluating clinical and product safety data, in training and managing staff...

Sommaire:

This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics: ? The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went. ? Study directors and principal investigators. ? The nuts and bolts of study performance. ? Electronic reporting requirements - SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions). ? Consultants and their roles. ? An expanded examination of common problems and their solutions. This book boastscomplete directories to the global universe of operating labs - where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities - and for auditing studies and projects at such facilities - are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide tothe global industry and this volume provides a complete update.

...

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Contract Research and Development Organizations-Their History, Selection, and Utilization - Gad, Shayne C.

Avis sur Contract Research And Development Organizations - Their History, Selection, And Utilization de Gad, Shayne C. Format... - Livre Médecine, Pharmacie, Paramédical, Médecine vétérinaire

Présentation Contract Research And Development Organizations - Their History, Selection, And Utilization de Gad, Shayne C. Format... - Livre Médecine, Pharmacie, Paramédical, Médecine vétérinaire

Présentation Contract Research And Development Organizations - Their History, Selection, And Utilization de Gad, Shayne C. Format...
- Livre Médecine, Pharmacie, Paramédical, Médecine vétérinaire