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Index
Title Page
Copyright Page
Preface
Chapter 1 - What Is A Drug?
Chapter 2 - Background
Economic Considerations
Risk Management
Key Personnel
Chapter 3 - Finding Potential Drugs: The Initial Preclinical Evaluation
Practical Evaluation of New Product Candidates
General Considerations
Choosing the Indication
Mechanism of Action
Potency
Metabolites
Initial Evaluations of Efficacy and Safety
Evaluations of Efficacy
Evaluation of Efficacy In Vitro
Evaluation of Efficacy In Vivo
Evaluations of Safety
Toxicology
Mutagenicity
Effects on Cardiac Conduction
General Toxicology Evaluations
Safety Pharmacology
Toxicokinetics
Metabolism
Evaluating the Risk/Benefit Ratio
Chapter 4 - Ethical Concerns and Legal Considerations
General Ethical Considerations
Special Situations
The Forgotten Ethical Issue
Legal Considerations
Chapter 5 - Initial Human Testing: The IND Application and Phase I Studies
The IND Application
Phase I Studies
The Single, Ascending-Dose Tolerance Study
The Multiple-Dose Tolerance Study
Special Evaluation of Cardiac Effects According to Worldwide Mandate
Substance Testing During Manufacture
Chapter 6 - Phase II Studies
Non-clinical Requirements for Initiation of Phase II
Design of Phase II Studies
Scientific Experts: Advisors and Investigators
Regulatory Review of the Proposed Phase II Study
Implementation of Phase II
Political and Business Considerations
Chapter 7 - Phase III Human Studies
Decision Point - Pressures and Considerations
Requirements for Initiation of Phase III
Implementation of Phase III Studies
Precautions for Implementation of Phase III Studies
Investigator Meeting
After the Meeting
Phase III Extension Studies
Chapter 8 - Late Stage Activities
Manufacturing
Non-clinical
Biopharmaceutics
Clinical Pharmacology
Integrating Late Stage Activities
Breaking the Blind and Final Steps
Political and Business Considerations
Chapter 9 - A Word on Phase IV Studies
Chapter 10 - NDA Submission and The NDA Submission Team
NDA Submission Team
Pre-NDA Meeting
General Considerations for Presenting NDA Data
NDA Documents
Chapter 11 - The NDA Review Process
Chapter 12 - The Challenges of Success
Chapter 13 - Types of New Drug Applications: 505b1, 505b2 and 505j NDAs
Chapter 14 - Inspections by Regulatory Agencies
Chapter 15 - Rules of Thumb and Other “Tricks of the Trade”
Evaluation of Personnel
Evaluation of Companies
Evaluation of Contract Research Organizations
Regulatory Approval Documents
FDA Advisory Committee Meetings
Costs and Timelines
The Value of Being Second to Market
Development of Products Already Approved in Other Countries
Collaborations Between Companies
Chapter 16 - Patents, Trademarks and Generic Names
Patents
Generic Name
Trademarks
National Drug Code
Product Appearance
Chapter 17 - Special Considerations for Investors
Accounting Considerations
Emotional Considerations
Evaluating Companies - General Considerations
Specific Issues
Risks and Considerations
Pre-IND
Phase I
Phase II
Phase III
Chapter 18 - Case Studies and Personal Anecdotes
Tacrine
Gancyclovir
A Disgusting Adverse Event
CGIC
Arithmetic
The Projected Market for Alzheimer’s Disease Treatments
Proton Pump Inhibitors
Criminal Misbranding
Death Penalty
Heart Attack
Chapter 19 - Safety Monitoring
Chapter 20 - Who Gets Drugs Approved
Chapter 21 - A Final Cautionary Note
Acknowledgements
Afterword
Glossary
Appendix 1 - Types of New Drug Applications
Appendix 2 - Inside Info: Open Secrets in the Pharmaceutical Industry
Appendix 3 - FDA Non-Clinical Guidance Document
Appendix 4 - Brief Discussion of Manufacturing Issues
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