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Bioanalytical studies are an integral aspect of biologic drug development, which might necessitate partnering with bioanalysis experts.
FREMONT, CA: Bioanalytical studies are essential in biologic drug development because the data from these studies are required to define the potential new biologics' characteristics. Bioanalyses data are also needed in inclusion in regulatory filings, driving the need for outsourcing the partners with in-depth bioanalytical experience and experience interacting with regulatory authorities.
Bioanalytical studies that are designed to give estimates for the concentration of drugs and biologics in pre-clinical and clinical studies of the therapeutic molecule or their metabolites are important for numerous aspects of human clinical pharmacology, studies related to bioavailability (BA)/bioequivalence (BE) evaluation, and few nonclinical studies needing concentration information for toxicokinetics, pharmacokinetics, or biomarkers. Bioanalytical work helps to supplement pivotal studies and aid in the decision-making process for safety, approval, and labeling of a drug or biologic; in short, without a proper bioanalytical data, the therapeutic product will not be approved.
Beyond the regulatory needs for conducting bioanalytical studies, the scientific importance of the data that these assays generate is invaluable. Bioanalytical assays offer data on certain safety aspects of the therapeutic in determining the maximum tolerated dosage. Pharmacokinetics (PK) scientists utilize the data to assess exposure, half-life, and various other pharmacological parameters used to guide the decisions on how often and how much of a therapeutic must be given for efficacy without undue toxicity.
Bioanalytical assays extend beyond measuring drug concentrations over time and are also leveraged to assess drug efficacy through pharmacodynamic (PD) endpoints. Biomarker assay results might provide early indicators of effectiveness, or also safety issues. They can also be used to stratify the patients to predict responders or non-responders. Another key bioanalytical assay for biotherapeutics is the assessment of immunogenicity. For vaccine development, a positive immunogenicity result might be considered the potential evidence that the vaccine is working as intended. Unwanted immunogenicity is more complicated as anti-drug antibodies' impact can influence the pharmacokinetics, efficacy, and safety, and has to be looked down at the individual patient level.