Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Harry Yang (Autor)

Buch | Hardcover

386 Seiten

2016
Chapman & Hall/CRC (Verlag)
978-1-4987-0415-1 (ISBN)

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The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A comprehensive resource, it combines in-depth explanations of advanced statistical methods with real-life case studies that illustrate practical applications of these methods in QbD implementation.

Harry Yang, Ph.D., is senior director and head of the Non-Clinical Biostatistics Group at MedImmune, the global biologics arm of AstraZeneca headquartered in Gaithersburg, Maryland.

BACKGROUND. Introduction. ANALYTICAL METHOD. Statistical Methods for Analytical Procedure Development, Validation and Transfer. Parallelism Testing of Bioassay. Validation of Assay Linearity. ROCESS DEVELOPMENT. Residual Host Cell DNA Risk Assessment. Statistical Evaluations of Viral Clearance. Pre-filtration Bio-burden Testing. Process Validation and Verification. MANUFACTURING. Specifications.

Erscheinungsdatum	22.02.2017
Reihe/Serie	Chapman & Hall/CRC Biostatistics Series
Zusatzinfo	30 Illustrations, black and white
Sprache	englisch
Maße	156 x 234 mm
Gewicht	703 g
Themenwelt	Mathematik / Informatik ► Mathematik
	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Studium ► Querschnittsbereiche ► Epidemiologie / Med. Biometrie
	Naturwissenschaften ► Biologie
	Sozialwissenschaften
	Technik
ISBN-10	1-4987-0415-8 / 1498704158
ISBN-13	978-1-4987-0415-1 / 9781498704151
Zustand	Neuware