Product/Service

Clinical Pharmacology

Source: QuintilesIMS
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.

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