Clinical drug trials and tribulations /
| Other Authors: | , , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York :
Marcel Dekker,
[2002]
|
| Edition: | Second edition, revised and expanded. |
| Series: | Drugs and the pharmaceutical sciences ;
v. 120. |
| Subjects: |
Table of Contents:
- Current challenges and future directions of drug development
- Preclinical drug discovery and development
- The IND process for new drug products
- Performance and interpretation of laboratory tests
- Issues in endpoint selection
- Dix, cent, mille : proof of principle with $10 million, 100 patients, and 1000 days
- Clinical trials in pediatrics : dilemmas of clinical drug trials in pediatric populations
- Electronic capture of clinical trial information
- Providing patient access to promising investigational drugs
- Issues in the review of clinical drug trials by IRBs
- Personal care and randomized clinical trials : understanding the ethical conflicts
- Informed consent in clinical trials : emerging issues
- Orphan drug development : David and Goliath
- Singel-event adverse drug reactions : tribulations in ascribing causality
- How to deal with a sudden, unexpected death in clinical studies
- Clinical trial material - the fuel for clinical research
- The role of pharmacokinetics in drug development
- Building an NDA/BLA
- International planning of drug clinical trials
- Uncertainty in drug development : approval success rates for new drugs
- Contract clinical research : value to in-house drug development
- Package inserts as viewed by the busy private practitioner
- New directions in pharmaceutical promotion : regulatory concerns and contrivances
- The campus researcher and industry : issues of intellectual property and technology transfer
- Anatomy of drug withdrawals in the United States