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International Stability Testing - Tapa dura

 
9781574910780: International Stability Testing
Tapa dura
ISBN 10: 1574910787 ISBN 13: 9781574910780
Editorial: CRC Press, 1998

Sinopsis

In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

"Sinopsis" puede pertenecer a otra edición de este libro.

Acerca del autor

David J. Mazzo

De la contraportada

In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

"Sobre este título" puede pertenecer a otra edición de este libro.

Editorial
CRC Press
Año de publicación
1998
Idioma
Inglés
ISBN 10 
1574910787
ISBN 13 
9781574910780
Encuadernación
Tapa dura
Número de edición
1
Número de páginas
350
Editor
Mazzo David J.
Contacto del fabricante
Taylor and Francis, GPSR Taylor and Francis
gpsr@taylorandfrancis.com

Taylor & Francis Verlag GmbH, Kaufingerstraße 24
München
80331
Alemania