SAD/MAD White Papers & Case Studies

1. Considerations When Selecting A CRO For Phase I Clinical Studies 6/17/2013

   Phase I clinical trials are an integral step in the drug development process. Specific factors can influence the timelines and success of these studies. This white paper addresses the critical success factors for Phase I clinical studies and provides guidance on the appropriate capabilities, expertise and experience to evaluate as a sponsor selects a CRO.

2. Human ADME & Studies With Radiolabeled Compounds

   During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences