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Global Approach in Safety Testing

Ich Guidelines Explained

Livre broché | Anglais | Aaps Advances in the Pharmaceutical Sciences | n° 5
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Description

This volume will consider one of ICH's major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the "lessons learnt" and "future developments".

Spécifications

Parties prenantes

Editeur:

Contenu

Nombre de pages :
315
Langue:
Anglais
Collection :
Tome:
n° 5

Caractéristiques

EAN:
9781489994073
Date de parution :
06-03-15
Format:
Livre broché
Format numérique:
Trade paperback (VS)
Dimensions :
156 mm x 234 mm
Poids :
458 g

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