Scientific Evaluation of Preclinical Program and Data Package

IND Program Planning and Management (CMC, Preclinical and Regulatory)

Preclinical Protocol Designs and Preclinical Study On-site Monitoring

Design and Review Preclinical and Clinical Pharmacokinetics Protocols

Advise on Bioanalytical Assays

Analyze and Model Data, including Writing of Toxicokinetics, Preclinical Pharmacokinetics and Clinical Pharmacokinetics Reports

Manuscript or presentation preparation

Review or Author Pharmacokinetics Documents and Responses for Regulatory Agencies