Statistical Design and Analysis in Pharmaceutical Science

Validation, Process Controls, and Stability

Shein-Chung Chow, Jen-Pei Liu (Autoren)

Buch | Hardcover

580 Seiten

1995
Crc Press Inc (Verlag)
978-0-8247-9336-4 (ISBN)

Artikel merken

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Chow, Shein-Chung; Liu, Jen-pei

Assay development; assay validation; scaleup design and analysis; USP tests and specifications; process validation; quality assurance; stability studies; accelerated testing; design for long-term stability studies; stability analysis with fixed batches; stability analysis with random batches. Appendices: statistical tables; SAS programs; regulations. references.

Erscheint lt. Verlag	22.2.1995
Verlagsort	Bosa Roca
Sprache	englisch
Maße	152 x 229 mm
Gewicht	1230 g
Themenwelt	Mathematik / Informatik ► Mathematik ► Angewandte Mathematik
	Mathematik / Informatik ► Mathematik ► Statistik
	Technik
ISBN-10	0-8247-9336-6 / 0824793366
ISBN-13	978-0-8247-9336-4 / 9780824793364
Zustand	Neuware