All your PK statistics analysis requirement with in-depth experts interpretation
PhinC Development pharmacokineticists provide precise analysis of data, whatever the purpose of your pharmacokinetic (PK) studies. PhinC Development covers all PK analysis requirements, 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. PhinC Development can quickly and precisely provide you with all the information needed to answer regulatory questions.
The Clinical Data Interchange Standards Consortium (CDISC) has been in place to streamline the submission of clinical study data.
From now on, PhinC Development can ensure your successful mapping strategy for submitting your PK data in a CDISC compliant format.
As many sponsors can attest, the preparation of CDISC-compliant datasets is time-consuming and costly. It is important to consider current and future data regulations when planning studies for your development program.
The CDISC standards associated with the analysis and submission of Pharmacokinetic (PK) data are the Standard for the Exchange of Nonclinical Data (SEND), Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM).
PhinC developed CDISC compliant PK workflows aiming both to consider all the specificities of the PK analyses and to match with the different types of working organization with data management, bioanalysis and regulatory affairs.
An example workflow incorporating SDTM datasets in a typical CDISC compliant PK is illustrated in the flow chart on the left.
Don't hesitate to get in touch with our CDISC experts! They are available to answer all your questions. CONTACT US!