ICH Quality Guidelines (ePub)
An Implementation Guide
(Sprache: Englisch)
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making....
sofort als Download lieferbar
eBook (ePub)
311.99 €
- Lastschrift, Kreditkarte, Paypal, Rechnung
- Kostenloser tolino webreader
Produktdetails
Produktinformationen zu „ICH Quality Guidelines (ePub)“
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines Uses case studies to help readers understand and apply ICH guidelines Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Autoren-Porträt
Andrew Teasdale, PhD, is a principal scientist in pharmaceutical development with AstraZeneca. He has over 20 years' experience within the industry and has held a number of leadership roles both internally and externally at a cross industry level encompassing key ICH topic areas.David Elder, PhD, is an independent CMC consultant. He has 40 years' experience within the pharmaceutical industry. He was formerly a director within GlaxoSmithKline's platform technology and science function. He is an expert member for the British Pharmacopoeia and has extensive CMC experience encompassing many of the key ICH topics.
Raymond W. Nims, PhD, is a Senior Consultant at RMC Pharmaceutical Solutions, with experience in a variety of GMP quality assurance and quality control topics from a biologics point of reference. He has served on ad hoc panels supporting a number of USP chapters and ANSI Standards.
Bibliographische Angaben
- 2017, 1. Auflage, 736 Seiten, Englisch
- Herausgegeben: Andrew Teasdale, David Elder, Raymond W. Nims
- Verlag: John Wiley & Sons
- ISBN-10: 1118971132
- ISBN-13: 9781118971130
- Erscheinungsdatum: 29.09.2017
Abhängig von Bildschirmgröße und eingestellter Schriftgröße kann die Seitenzahl auf Ihrem Lesegerät variieren.
eBook Informationen
- Dateiformat: ePub
- Größe: 29 MB
- Mit Kopierschutz
Sprache:
Englisch
Kopierschutz
Dieses eBook können Sie uneingeschränkt auf allen Geräten der tolino Familie lesen. Zum Lesen auf sonstigen eReadern und am PC benötigen Sie eine Adobe ID.
Kommentar zu "ICH Quality Guidelines"
0 Gebrauchte Artikel zu „ICH Quality Guidelines“
Zustand | Preis | Porto | Zahlung | Verkäufer | Rating |
---|
Schreiben Sie einen Kommentar zu "ICH Quality Guidelines".
Kommentar verfassen