Nonclinical
Pharmacology and Pharmacokinetics
Pharmacology and Pharmacokinetics services include study design, conduct, data analysis, report writing and submissions. Here are some of the services Pacific BioDevelopment offers in this arena:
- Strategic development and implementation of Phase-appropriate non-clinical absorption, distribution, metabolism, and excretion (ADME) development programs in concert with the toxicology program
- Design, oversee, and analyze data for clinical and non-clinical pharmacokinetic studies
- Prepare for and/or participate in FDA meetings
- Optimize clinical dose selection using pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) modeling data
- Due diligence for in-licensing opportunities
- Draft and/or review reports and ADME sections for regulatory submissions
- Provide interim management and oversight for clients without internal staff
