Bioanalytical Services

PRU bioanalytical services provide fast turnaround times, quality, and precision via our laboratory’s state-of-the-art equipment and experienced scientists with many years of pharmaceutical and bioanalytical study experience. Our services include:

  • Bioanalytical Method Development:

    Optimization of the LC/MS/MS and extraction procedures for optimal sensitivity, recovery, and reproducibility.

  • Bioanalysis:

    Determination of the concentration of a test agent in biological samples using our state-of-the-art analytical equipment.

  • Validation parameters:

    Selectivity, Carry over, Sensitivity, Calibration curve, Dilution Integrity, Accuracy & Precision, Stability, Recovery, Matrix effect.

Contact us to discuss your bioanalytical needs.

Ask us how we might be able to address your unique bioanalytical needs.

Bioanalytical Services Purpose and Place

Bioanalytical testing provides quantitative measurement of an active drug and/or its metabolites in biological matrices (plasma, brain tissue, urine etc.). Custom specific and sensitive bioanalytical methods are required to make these measurements. PRU bioanalytial lab employs state-of-the-art high-throughout LC/MS/MS and HPLC equipment to offer the most sensitive bioanalytical method possible.

Our bioanalytical lab offers bioanalytical services separately or in conjunction with our other CRO services essential for evaluation of drug-like properties of your molecules including:

  • Pharmacokinetic Studies (PK)
  • Pharmacodynamic Studies

 

Qualified Persons

In line with EU cGMP requirements, we have designated Qualified Persons (QPs) who are available to provide either a full or partial certification step for Investigational Medicinal Products.