Donald Heald

TL;DR: The physiologically based modeling approach has been used to model the absorption of a lipophilic BCS Class II compound predominantly metabolized by CYP3A4, and to assess the interplay of absorption related parameters with the drug–drug interaction (DDI) potential.

TL;DR: In this review, the Innovation and Quality in Pharmaceutical Development's Clinical Pharmacology Leadership Group (CPLG) provides a compelling rationale for the use of itraconazole as a replacement for ketoconazole in clinical DDI studies and provides recommendations on the best practices for the Use of itRaconazoles in such studies.

TL;DR: Integration of the neuroPK parameters with pharmacodynamic readouts demonstrated the value of the proposed approach in the evaluation of target engagement and NCE selection, thereby optimizing the routine of evaluation and selection of novel neurotherapeutics.

TL;DR: Interpretable molecular descriptors that significantly contribute to the three key neuropharmacokinetic properties related to BBB drug transport, intracellular accumulation, and binding and distribution in the brain for a set of 40 compounds were identified using partial least-squares analysis.

TL;DR: A cell-level in vitro PD model was developed that quantitatively characterized CAR-T cell-induced target cell depletion, CAR-t cell expansion and cytokine release and an integrated PBPK-PD relationship was established to simultaneously characterize expansion ofCAR-T cells and tumor growth inhibition (TGI) in xenograft mouse model, using datasets from anti-BCMA, anti-HER2,Anti-CD19 and anti-EGFR CAR- T cells.