New Drug Development

1. Front Matter

   Pages i-xxv

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2. New Drug Development

   • J. Rick Turner

   Pages 1-10

3. The Regulatory Environment

   • J. Rick Turner

   Pages 11-20

4. Drug Discovery

   • J. Rick Turner

   Pages 21-34

5. Nonclinical Research

   • J. Rick Turner

   Pages 35-46

6. Designing Clinical Trials

   • J. Rick Turner

   Pages 47-67

7. Conducting Clinical Trials I: Experimental Methodology

   • J. Rick Turner

   Pages 69-78

8. Conducting Clinical Trials II: Operational Execution

   • J. Rick Turner

   Pages 79-97

9. Statistical Analysis

   • J. Rick Turner

   Pages 99-114

10. Statistical Significance

    • J. Rick Turner

    Pages 115-133

11. Clinical Significance

    • J. Rick Turner

    Pages 135-141

12. Sample Size Estimation

    • J. Rick Turner

    Pages 143-151

13. General Safety Assessments

    • J. Rick Turner

    Pages 153-164

14. Efficacy Assessment

    • J. Rick Turner

    Pages 165-193

15. Cardiac and Cardiovascular Safety Assessments

    • J. Rick Turner

    Pages 195-210

16. Manufacturing Small Molecule Drugs and Biologicals

    • J. Rick Turner

    Pages 211-219

17. Postmarketing Surveillance

    • J. Rick Turner

    Pages 221-231

18. Main Themes and Concluding Comments

    • J. Rick Turner

    Pages 233-245

19. Back Matter

    Pages 247-256

    PDF

New Drug Development: Second Edition provides an overview of the design concepts and statistical practices involved in therapeutic drug development. This wide spectrum of activities begins with identifying a potentially useful drug candidate that can perhaps be used in the treatment or prevention of a condition of clinical concern, and ends with marketing approval being granted by one or more regulatory agencies. In between, it includes drug molecule optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The more inclusive term lifecycle drug development can be used to encompass the postmarketing surveillance that is conducted all the time that a drug is on the market and being prescribed to patients with the relevant clinical condition. Information gathered during this time can be used to modify the drug (for example, dose prescribed, formulation, and mode of administration) in terms of its safety and its effectiveness. The central focus of the first edition of this book is captured by its subtitle, 'Design, Methodology, and Analysis'. Optimum quality study design and experimental research methodology must be employed if the data collected—numerical representations of biological information—are to be of optimum quality. Optimum quality data facilitate optimum quality statistical analysis and interpretation of the results obtained, which in turn permit optimum quality decisions to be made: Rational decision making is predicated on appropriate research questions and optimum quality numerical information. The book took a non-computational approach to statistics, presenting instead a conceptual framework and providing readers with a sound working knowledge of the importance of design, methodology, and analysis. Not everyone needs to be an expert in statistical analysis, but it is very helpful for work (or aspire to work) in the pharmaceutical and biologics industries to be aware of the fundamental importance of a sound scientific and clinical approach to the planning, conduct, and analysis of clinical trials.

• Clinical
• Development
• Drug
• Introduction
• Trial
• Turner
• methodology

From the reviews of the second edition:

“‘New Drug Development: An Introduction to Clinical Trials, 2^nd Edition’ is a solid introduction to the process of drug development, with an emphasis on clinical research, especially the statistical aspects. It is ideal for readers interested in clinical research within the broader context. The book is written in a practical and straightforward manner … .” (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 9 (5), May, 2013)

• Cardiac Safety Services, Quintiles, Durham, USA

  J. Rick Turner

Dr. Rick Turner is an experimental research scientist, clinical trialist, and author. He was awarded his doctoral degree in the field of Cardiovascular Behavioral Medicine in 1984. His innovative genetic research in that discipline led to 50 peer-reviewed papers, five books, and two international research awards. Fifteen years ago Dr. Turner moved into the pharmaceutical industry, holding positions as a Clinical Submissions Scientist at GlaxoSmithKline and as President and Chief Scientific Officer at Turner Medical Communications LLC. He is now Senior Scientific Director, Cardiac Safety Services, at Quintiles, the world’s largest pharmaceutical contract research organization. His work focuses on assessing the cardiac safety of non-cardiac drugs. He has spoken before two FDA Advisory Committees on cardiovascular safety issues, given numerous presentations at international conferences, and published several recent peer-reviewed papers in this field. He is also the senior author of 'Integrated Cardiac Safety: Assessment Methodologies for Noncardiac Drugs in Discovery, Development, and Postmarketing Surveillance' (Turner and Durham, 2009).

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