Regulated Bioanalysis: Fundamentals and Practice

✍ Scribed by Mario L. Rocci Jr., Stephen Lowes (eds.)

• Publisher: Springer International Publishing
• Year: 2017
• Tongue: English
• Leaves: 239
• Series: AAPS Advances in the Pharmaceutical Sciences Series 26
• Edition: 1
• Category: Library

✦ Synopsis

The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.

✦ Table of Contents

Front Matter....Pages i-xiii
Introduction....Pages 1-13
Understanding Bioanalysis Regulations....Pages 15-38
Logistical and Operational Practice in the Regulated Bioanalysis Laboratory....Pages 39-62
Regulated Bioanalysis: Documentation and Reports....Pages 63-85
Regulated Bioanalysis—Historical Aspects and Key Concepts Related to Its Use....Pages 87-102
Fundamentals of LC-MS/MS for Regulated Bioanalysis....Pages 103-120
Liquid Chromatography–Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory....Pages 121-153
Development and Maintenance of Critical Reagents for Ligand Binding Assays to Support Regulatory-Compliant Bioanalysis....Pages 155-176
Ligand Binding Assays in the Regulated Bioanalytical Laboratory....Pages 177-228
Back Matter....Pages 229-230

✦ Subjects

Pharmaceutical Sciences/Technology