Preclinical development programs Phase 3 supports

Improvement of sensitivity of the bioanalytical method is often needed to support PK evaluation of drug candidate during clinical development. This sensitivity requirement is mainly due to the fact that the phase I doses are usually much lower than the doses administrated during the preclinical development phase. An HPLC-MS/MS method had been validated in rat, dog, and mouse plasma for support of a preclinical development program. A summary of the validation parameters in rat plasma are given in Table 8.8. 

Plan strategically. The entire integrated development program should be planned early, to identify when each clinical phase will require the supportive preclinical information. Critical decision points must be identified and these decisions made in a timely fashion. A strategy must be planned to address potential issues, such as lack of a relevant species or changes to the product or manner of use. 

---