Clinical Pharmacology
Clinical Pharmacology – Scientific Steps in Safety
To move from Phase I to Phase IIa and then to guide the dosing-regimen design for Phase III studies, you need to:
- Promote the safety of your drug by maximizing the benefits and minimizing the side effects
- Effectively communicate with regulatory agencies
We provide the full spectrum of Pharmacokinetic (PK) / Pharmacodynamic (PD) services – from coordinating First-in-Human studies to negotiating pharmacokinetics labeling. With our scientists, we work to:
- Integrate early development PK/PD data to design First-in-Human studies and support registration, including estimating doses
- Assess Phase I safety/dose tolerance
- Accelerate Phase I/IIa proof of concept
- Establish definitive QT
- Study human metabolic fate/mass balance
- Prepare components of IND, CTD, and NDA submissions
- Support for end-of-Phase II, pre-NDA and advisory panel meetings
- Perform PK/PD modeling to guide dosing-regimen design for Phase III studies
