Statistical Design and Analysis in Pharmaceutical Science

Validation, Process Controls, and Stability

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

Buch | Softcover

580 Seiten

2019
CRC Press (Verlag)
978-0-367-40187-0 (ISBN)

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"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.

Erscheinungsdatum	18.09.2019
Verlagsort	London
Sprache	englisch
Maße	152 x 229 mm
Gewicht	453 g
Themenwelt	Mathematik / Informatik ► Mathematik ► Statistik
	Naturwissenschaften ► Biologie
	Technik
ISBN-10	0-367-40187-8 / 0367401878
ISBN-13	978-0-367-40187-0 / 9780367401870
Zustand	Neuware