Design of ADME and PK studies across species

Selection of appropriate in vitro and in vivo models

Guidance on dose selection, sampling schedules, and formulation strategies

Metabolite Identification: Design in vitro and in vivo Met ID strategies to characterize metabolic pathways, identify soft spots, and support safety assessments early in development

Non-compartmental and compartmental PK analysis

PBPK modeling to predict human pharmacokinetics

PK/PD modeling to support dose rationale and efficacy projections

Exposure-response and target engagement modeling

Interpretation of metabolic stability, protein binding, and permeability data

Evaluation of CYP inhibition, induction, and reaction phenotyping

Assessment of transporter interactions (e.g., P-gp, BCRP, OATP)

Prediction of drug-drug interaction (DDI) risk using mechanistic models

Authoring and reviewing IND, NDA, and BLA sections related to DMPK

Preparation of summary tables, study reports, and justification narratives

Response strategies for regulatory queries and health authority feedback

Alignment with FDA, EMA, and ICH M10 expectations

Translating complex DMPK findings into actionable insights for non-specialists

Advising on candidate selection, go/no-go decisions, and portfolio prioritization

Supporting clinical pharmacology and formulation development teams

Bridging gaps between discovery, development, and regulatory affairs

Streamlining bioanalytical workflows and data pipelines

Troubleshooting LC-MS/MS, automation platforms, and data integrity issues

Enhancing protocol clarity to minimize deviations and improve compliance