Regulated Bioanalysis: Fundamentals and Practice

1. Front Matter

   Pages i-xiii

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2. Introduction

   • Stephen Lowes, Mario L. Rocci Jr.

   Pages 1-13

3. Understanding Bioanalysis Regulations

   • Mark Arnold, Eric Fluhler, Boris Gorovits

   Pages 15-38

4. Logistical and Operational Practice in the Regulated Bioanalysis Laboratory

   • Patrick Bennett, Richard M. LeLacheur

   Pages 39-62

5. Regulated Bioanalysis: Documentation and Reports

   • Surendra K. Bansal, Faye Vazvaei

   Pages 63-85

6. Regulated Bioanalysis—Historical Aspects and Key Concepts Related to Its Use

   • Sheila Breidinger, Eric Woolf

   Pages 87-102

7. Fundamentals of LC-MS/MS for Regulated Bioanalysis

   • Gary Schultz, Jack Henion

   Pages 103-120

8. Liquid Chromatography–Mass Spectrometry Assays in the Regulated Bioanalytical Laboratory

   • Stephanie S. Cape, Min Meng, Mohammad R. Koupaei-Abyazani, Douglas M. Fast

   Pages 121-153

9. Development and Maintenance of Critical Reagents for Ligand Binding Assays to Support Regulatory-Compliant Bioanalysis

   • William Nowatzke, Franklin Spriggs, Van Fitzgerald, Aleks Davis, Ronald R. Bowsher

   Pages 155-176

10. Ligand Binding Assays in the Regulated Bioanalytical Laboratory

    • Johanna Mora, Charles Hottenstein, Binodh DeSilva

    Pages 177-228

11. Back Matter

    Pages 229-230

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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.  

• bioanalytical
• biology
• chemistry
• laboratory documentation
• pharmaceutical sciences

• Laboratory Services, ICON, Plc, Whitesboro, USA

  Mario L. Rocci Jr.

• Bioanalytical and ADME Labs, Q Squared Solutions, Ithaca, USA

  Stephen Lowes

Mario Rocci earned a Ph.D. in Pharmaceutics and a B.S. in Pharmacy from the State University of New York at Buffalo. He then joined Prevalere and developed the Pharmaceutical and Chemical Analysis business sector. Mario is well known throughout the pharmaceutical industry and has served as the President of the American Association of Pharmaceutical Scientists (AAPS), a professional society of over 13,000 members. He also serves on the Board of Pharmaceutical Sciences for the International Pharmaceutical Federation (FIP) and is Chairman of the Board of the Product Quality Research Institute (PQRI). Dr. Rocci has authored over 125 scientific publications and has extensive experience in the pharmaceutical sciences and the regulatory requirements of the FDA. He has over 25 years of experience in the pharmaceutical industry.

Stephen Lowes is Senior Scientific Direct of Bioanalysis and ADME Services at Q2 Solutions. He earned his Ph.D. in analytical chemistry from the Open University, United Kingdom. Dr. Lowes started his industrial career at VG Biotech in the UK that became the LC/MS instrument entity of Waters Corporation. He then joined the CRO group that became Advion and focused his career on regulated bioanalysis with particular emphasis on LC/MS. He has remained very connected on regulatory developments in bioanalysis and is a founding member of the Global Bioanalysis Consortium (GBC) and a past-chair of the AAPS Bioanalytical Focus Group. Dr. Lowes has more than 40 peer reviewed publications on bioanalysis and is a frequent speaker at national and international conferences.

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