PK bioanalytical analysis

 

Our group has extensive experience in the development and validation of bioanalytical assays to support preclinical and clinical PK studies (Data processing and modeling will be supervised by Nathan Hanan PharmD, a clinical pharmacologist, with over 10 years experience in pharmacometrics). Our experience supporting PK analyses has been over a wide range of pharmacotherapeutics, such as antiretrovirals, pyschotropes, antimicrobials, antifungals and chemotherapy agents. We have experience analyzing analytes in numerous biomatrices including plasma, whole blood, dried blood spots, peripheral blood mononuclear cells (PBMCs), and urine. We are knowledgeable on bioanalytical method validations guidelines and will work with you to meet your needs.

 

PK/PD analysis, statistics, and reporting

 

In addition to PK bioanalytical analyses, consider us as a one-stop shop for all of your pharmacometric needs. We can work with you to integrate all of your PK concentration, demographic, chemistry, biomarker, and dosing information.  Our PK/PD analysis services include:

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• Non-compartmental (NCA) analyses

• PK/PD modeling and simulation

• Optimization of PK study design

• Biometrics and programming

• Protocol and study design review

• Manuscript and report generation

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