Name: pharmaceutical stability testing to support global markets (en Inglés)
Price: 245240.00 CLP
Availability: InStock
Author: Huynh-Ba, Kim
ISBN: 9781461425366

portada pharmaceutical stability testing to support global markets (en Inglés)

Formato

Libro Físico

Ilustrado por

Kim Huynh-Ba

Editorial

Springer

Autor

Huynh-Ba, Kim

Año

2012

Idioma

Inglés

N° páginas

266

Encuadernación

Tapa Blanda

Dimensiones

25.4 x 17.8 x 1.5 cm

Peso

0.50 kg.

ISBN

1461425360

ISBN13

9781461425366

Categorías

Ciencias básicas de la medicina preclínica
Farmacología
Farmacia y prescripción
Biotecnología

pharmaceutical stability testing to support global markets (en Inglés)

Kim Huynh-Ba (Ilustrado por) · Springer · Tapa Blanda

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Reseña del libro "pharmaceutical stability testing to support global markets (en Inglés)"

The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops - the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.