Pharmacokinetics NCA
A comprehensive study of the Pharmacokinetics (PK) of your drug candidate
From the development of study protocols to the analysis of bioanalytical data and expert interpretation of the results, the pharmacokineticists at PhinC Development cover all aspects of the pharmacokinetic study of the investigational compound, including:
- Dose and time linearity studies
- Drug-Drug interactions
- Gender and age impacts on the drug metabolism and pharmacokinetic (DMPK) of drugs
- Impact of hepatic or renal insufficiency on pharmacokinetic
- Bioequivalence studies
Calculations of PK parameters are performed according to standard international definitions. Calculations are then followed by in-depth interpretation of the PK parameters by senior scientists.
PhinC Development team offers the most accurate results mastering the recognized software packages: WinNonlin® and SAS. We can quickly and precisely provide you with all the information needed to answer regulatory questions.
The quality of the results delivered by PhinC Development also relies on:
- our frequent interactions with health authorities,
- our knowledge of regulatory submission standards,
- and our command of industry-recognized software: WinNonlin and SAS.
PhinC Development can quickly and accurately provide you with all the information needed to address regulatory questions.
The Clinical Data Interchange Standards Consortium (CDISC) was established to streamline the submission of data to regulatory agencies.
PhinC Development can now format your bioanalysis and PK data in CDISC-compliant format.
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