In September, Ad F. Roffel, Ph.D., Director of Scientific Affairs - Clinical Pharmacology, presented in Munich, Germany on The Changing Landscape of ADME Studies: A Discussion of the Challenges and Opportunities in Practical Application.
Some of the key points of his discussion:
- Increasingly, we have seen that investigational compounds have properties that make the design and conduct of human ADME studies a challenge: poor solubility, complex metabolism, tissue retention, slow elimination
- There is an interesting new development in bioanalysis of 14C: CRDS
- Microtracer human ADME studies have an established role in the field today
- There are really two strategies for doing human ADME studies in industry, i.e., either do them very early (and de-risk compounds early); or wait until proof of concept /efficacy has been demonstrated ( and keep the money in the pocket until you really need to spend it)