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The BioPharm Team offers consulting on pharmacokinetics (PK) and toxicokinetics (TK) programs including:
- Strategic assistance with PK/TK study design and selection
- Assistance with outsourcing and managing preclinical PK/TK studies to support initiation of clinical studies
- Nonclinical and clinical PK/TK data analysis, interpretation, and report preparation
- Assistance with addressing questions from regulatory authorities
- Preparation and writing of the pharmacokinetic and toxicokinetic portions of regulatory submissions (e.g., INDs, NDAs, and CTDs)
BioPharm Team consultants who offer these services:
Kathleen Baran, Ph.D., DABT
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