Achieving Optimal Preclinical Formulation And Drug Product Manufacture

Developing and manufacturing drugs for preclinical testing marks a crucial initial phase preceding human trials. During this preclinical stage, the primary objective is to ensure maximum exposure for safety evaluation by formulating the drug to its solubility and volume limits.

To optimize drug formulations for preclinical testing, several critical factors must be considered. These include determining the appropriate route of administration, selecting suitable excipients, conducting stability testing, devising plans for scale-up, and establishing contingency measures.

In this edition, we delve into the essential considerations for successful formulation development and manufacturing aimed at safety assessment. Additionally, we examine the strategies employed by Altasciences to support sponsors throughout this process.