New drug development : regulatory paradigms for clinical pharmacology and biopharmaceutics /
| Other Authors: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York :
Marcel Dekker,
2004.
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| Series: | Drugs and the pharmaceutical sciences ;
141. |
| Subjects: |
Table of Contents:
- History and basic principles
- Introduction to drug development and regulatory decision making
- Evolution of drug development and its regulatory process
- Regulatory bases for clinical pharmacology and biopharmaceutics information in a new drug application
- New drug application content and review process for clinical pharmacology and biopharmaceutics
- In vitro/pre-clinical
- In-vitro drug metabolism studies during development of new drugs
- Drug transporters
- Principles, issues, and applications of interspecies scaling
- Clinical pharmacology
- Analytical method validation
- Studies of the basic pharmacokinetic properties of a drug : a regulatory perspective
- Surrogate markers in drug development
- Population pharmacokinetic and pharmacodynamic analysis
- Scientific and regulatory considerations for studies in special population
- Conducting clinical pharmacology studies in pregnant and lactating women
- Scientific, mechanistic, and regulatory issues with pharmacokinetic drug-drug interactions
- Assessing the effect of disease state on the pharmacokinetics of the drug
- Clinical pharmacology issues related to specific drug classes during drug development
- Biopharmaceutics
- Issues in bioequivalence and development of generic drug products
- Regulatory considerations for oral extended release dosage forms and in vitro (dissolution)/in vivo (bioavailability) correlations
- In vivo bioavailability/bioequivalence waivers
- Bioavailability and bioequivalence issues for drugs administered via different routes of administration; inhalation/nasal products; dermatological products, suppositories
- Contemporary and special interest topics
- Scientific and regulatory issues in development of chiral drugs
- A regulatory view of liposomal drug product characterization
- Challenges in drug development : biological agents of intentional use
- The regulation of antidotes for nerve agent poisoning
- Bioequivalence assessment : approaches, designs, and statistical considerations