Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues.
After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources.
Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.
Keywords: drug development preclinical candidate phase-one clinical trials first-in-human studies process technology pharmacology intellectual property prediction pharmacokinetics pharmacodynamics safety case studies, Clinical & Experimental Medical Research, Pre-Clinical/Clinical Development, Clinical & Experimental Medical Research, Pre-Clinical/Clinical Development
- Buschmann, Helmut
- Giordanetto, Fabrizio
- Holenz, Jörg
- Mannhold, Raimund
- John Wiley and Sons, Inc.
- Publication year
- Methods and Principles in Medicinal Chemistry
- Page amount
- 816 pages
- Gardening, Agriculture, Forestry
- eISBN (ePUB)
- Printed ISBN