PK/PD
We provide extensive pharmacokinetic (PK) and pharmacodynamic (PD) support - as part of our Biostatistics services - in Phase 1-3 clinical studies in accordance with international regulatory standards (FDA, EMEA, and ICH).
We offer human pharmacology services that include, but are not limited to, single- and multiple-dose PK studies, bioavailability studies, bioequivalence studies, drug-drug interaction studies (DDI), population PK, and PK/PD or dose-response studies.
Additionally, we provide the following related services to our biopharmaceutical clients:
- Pharmacokinetic study design
- Consulting and liaison with regulatory agency officials
- Pharmacokinetic protocol authorship
- Pharmacokinetic data analysis and modeling
- Pharmacokinetic clinical study report writing
News
Business is very healthy at life sciences firm Clinipace
Recent news that Quintiles, the world's largest contract research organization and life sciences services firm, made some layoffs shows quite clearly that the CRO business is not immune to continuing ups and downs in the global economy. But at Clinipace Worldwide, a CRO based in Morrisville, the "We're Hiring" sign is out after what the company describes as a record year in 2010.
