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Case Studies

Due Diligence to Support a Client’s Decision-Making

Background & Problem A client needed due diligence performed on the preclinical data, translational dose rationale and first-in-human (FIH) clinical protocol for a central nervous system (CNS) small molecule, indicated for a chronic neurodegenerative orphan disease. Our Solution Preclinical Absorption, Distribution, Metabolism, and Excretion (ADME),… Read more

Using PBPK to Extrapolate Animal Tissue Concentrations to Humans

Background & Problem An approved small molecule therapeutic had shown efficacy in numerous target organs of interest in clinical trials. The client wished to show that this efficacy was explained by high drug penetration into these tissues. Our Solution Mouse biodistribution data was collected. A… Read more

End-to-End 505(b)(2) Submission Support

Background & Problem The client needed guidance on their program from start to finish, and there were complications obtaining the reference listed drug (RLD). We engaged the client prior to the IND-enabling program by conducting a gap analysis (US IND and EU IMPD submissions) and… Read more

Successful Lactation Study Design for Single Dose PK Profile

Background & Problem The Sponsor was developing a therapy that could be administered to women undergoing childbirth via Caesarean section. Since the drug would have no benefit to the infant, the Sponsor was required to evaluate how much of the drug formulation could be passed… Read more