Bioanalytical Laboratory Services for Accurate and Reliable Results
BioAgilytix San Diego, formerly MicroConstants, performs industry-standard DMPK assays, custom drug metabolism research, and IND-enabling studies, to assess drug-drug interaction potential, metabolic stability, metabolite profiling, and protein binding.
Understanding the PK profile of a given therapeutic is an essential element of assessing its efficacy and safety. PK evaluations help to define the proper dosage, route, and schedule of administration during preclinical and clinical studies.
PD assessments in early drug development studies can provide vital information on biological effects to help the design of later clinical studies to improve treatment. PD biomarkers are used in preclinical and clinical studies for establishing dosing regimens and therapeutic efficacy.
Immunogenicity risk assessment is critical to the development of most therapeutic modalities. It can affect both safety and efficacy, ranging from no evidence of clinical effect to severe, life-threatening responses. Assessment of undesirable immunogenicity of therapeutics is a key element in drug development.
Biomarker analysis enables you to assess a therapeutic’s efficacy, safety, and mechanism of action to make go/no go decisions during the drug development process. Biomarker assays can also validate targets and identify potential toxicity.
CMC bioanalytical testing is required for all drug development programs. These assays are used to monitor the drug manufacturing processes and ensure the safety, efficacy, and quality of pharmaceutical products. CMC bioanalytical strategies are inherently complex and must be individualized for each therapeutic program.