Nonclinical statistics for pharmaceutical and biotechnology industries. (2016)

• Record Type: Book
• Further Information: Note: Lanju Zhang, editor ; Max Kuhn, Ian Peers, Stan Altan, section editors.
• Editors: Zhang, Lanju
• Contents: Introduction to Nonclinical Statistics for Pharmaceutical and Biotechnology Industries -- Regulatory Nonclinical Statistics -- How to be a good nonclinical statistician -- Statistical Methods for Drug Discovery -- High-throughput Screening Data Analysis -- Quantitative-Structure Activity Relationship Modeling and Cheminformatics -- GWAS for Drug Discovery -- Statistical applications in Design and Analysis of In-Vitro Safety Screening Assays -- Nonclinical safety assessment: an introduction for statisticians -- General Toxicology, Safety Pharmacology, Reproductive Toxicology and Juvenile Toxicology Studies -- Clinical Assays for Biological Macromolecules -- Recent Research Projects by FDA's Pharmacology and Toxicology Statistics Team -- Design and evaluation of drug combination studies -- Biomarkers -- Overview of Drug Development and Statistical Tools for Manufacturing and Testing -- Assay Validation -- Lifecycle Approach to Bioassay -- Quality by Design: Building Quality into Products and Processes -- Process Validation -- Acceptance Sampling -- Process Capability and Statistical Process Control -- Statistical Considerations for Stability and the Estimation of Shelf Life.- In Vitro Dissolution Testing: Statistical Approaches and Issues -- Assessing Content Uniformity -- Chemometrics and Predictive Modelling -- Statistical Methods for Comparability Studies.
• Publisher Details: Cham : Springer
• Publication Date: 2016
• Extent: 1 online resource (xxii, 698 pages), illustrations (some color)
• Subjects: 615/.1072; Statistics; Pharmacology -- Statistical methods; Biotechnology -- Statistical methods; Biotechnology -- Statistical methods; Drug Discovery -- methods; Statistics as Topic; Medical -- General; Medical -- Pharmacology; Medicine: general issues; Pharmacology; Medicine; Toxicology; Medical -- Biostatistics; Probability & statistics; Electronic books
• Languages: English
• ISBNs: 9783319235585; 3319235583; 3319235575; 9783319235578
• Related ISBNs: 9783319235578
• Notes: Note: Online resource; title from PDF title page (SpringerLink, viewed January 21, 2016).
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.