Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing. (2016)

• Record Type: Book
• Other Names: Yang, Harry
• Contents: Cover ; Half Title ; Title Page ; Copyright Page ; Table of Contents ; Preface ; Section I: Background; 1: Quality by Design in Biopharmaceuticals; 1.1 Introduction 1.2 Evolving Regulatory Environment 1.3 Bioprocess Development ; 1.3.1 Upstream Process ; 1.3.2 Downstream Process 1.3.3 Challenges of Bioprocessing 1.4 Quality by Design ; 1.4.1 Quality Target Product Profile ; 1.4.2 Product and Process Design 1.4.2.1 Critical Quality Attributes 1.4.2.2 Process Development ; 1.4.3 Process Control ; 1.4.4 Contrast between Minimal Approaches and 1.5 Statistical Opportunities 1.5.1 Analytical Method QbD ; 1.5.2 CQAs and Clinical Performance ; 1.5.3 Design Space
• Publisher Details: Place of publication not identified : CRC Press
• Publication Date: 2016
• Extent: 1 online resource, illustrations
• Subjects: 615.2; MEDICAL / Biostatistics; Biometry -- Statistical methods; Pharmaceutical biotechnology industry; MEDICAL / Pharmacology; Electronic books
• Languages: English
• ISBNs: 1498704166; 9781498704168
• Related ISBNs: 1498704158; 9781498704151
• Notes: Note: Print version record.
• 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.