Why Partner with Bioanalysis Experts?

Bioanalytical studies are a key aspect of biologic drug development that may necessitate collaborating with bioanalysis experts.

FREMONT, CA: Today, it is widely accepted that bioanalysis is a vital part of the pharmacodynamic characterization of a novel chemical entity from the time of its discovery and during several stages of drug development, leading to its market authorization. The bioanalytical parameters and their application to drug discovery and development approaches will support the development of safe and more efficacious drugs with reduced development time and cost. Bioanalyses data are also an essential inclusion in regulatory filings, driving the demand for outsourcing partners with in-depth bioanalytical experience and experience interacting with regulatory authorities. Here is more about the need for partnering for bioanalytical studies.

Bioanalytical studies, which are tailored to offer estimates for the concentration of drugs and biologics in preclinical and clinical studies of the therapeutic molecule or their metabolites, are vital for several aspects of human clinical pharmacology, studies related to bioavailability evaluation, and some nonclinical studies needing concentration information for pharmacokinetics, toxicokinetics, or biomarkers. Bioanalytical work serves to supplement key studies and aid in the decision-making process for approval, safety, and/or labeling a drug or biologic. 

Without proper bioanalytical data, the therapeutic product would not be approved.

Beyond the regulatory needs for conducting bioanalytical studies, the importance of the data that these assays create is invaluable. Bioanalytical assays offer information on many safety aspects of the therapeutic in deciding the maximum tolerated dose. Pharmacokinetics use the information to decide exposure, half-life, and other pharmacological parameters, which are leveraged to guide decisions on how often and how much of a therapeutic should be given for efficacy without undue toxicity.

The requirement for sound bioanalytical methods is well understood in the discovery phase and during the preclinical and clinical stages of drug development. Therefore, it is accepted that sample preparation and method validation are needed to demonstrate the method's performance and the reliability of the analytical outcomes. The acceptance factor should be established in a validation plan before the initiation of the validation study. The developed assay should be rugged in that it offers opportunities for minor modifications to suit other bioanalytical requirements such as applicability to a drug–drug interaction study, toxicokinetic study, and characterization of the plasma levels of the metabolites.