Our Bioanalytical Services
BIOANALYTICAL SERVICES Toxicokinetics (TK)
Toxicokinetics (TK) is essential for assessing toxicity and determining safe exposure levels. It describes the behavior and effects of drugs at very high doses, mostly carried out in animals in preclinical studies.
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BIOANALYTICAL SERVICES Pharmacokinetics (PK)
Understanding the pharmacokinetic (PK) profile of a specific therapeutic is crucial for evaluating both its effectiveness and safety. PK assessments aid in determining the appropriate dosage, route, and schedule of drug administration in preclinical and clinical studies.
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BIOANALYTICAL SERVICES Pharmacodynamics (PD)
Early drug development studies utilize pharmacodynamic (PD) assessments to glean essential insights into biological effects and guide dosing regimens and treatment strategies in the design of later clinical studies. PD biomarkers play a pivotal role in establishing therapeutic efficacy.
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BIOANALYTICAL SERVICES Immunogenicity (ADA/NAb)
Immunogenicity risk assessment is critical to the development of most therapeutic drugs. Its impact ranges from negligible clinical effects to severe, life-threatening responses. Securing a safe and efficient drug by determining undesirable immunogenicity effects is crucial to drug development.
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BIOANALYTICAL SERVICES Biomarker Testing
In drug development, biomarker analysis helps in the assessment of candidate drugs, where they can be used to validate targets, prove mechanisms of action, predict efficacy, and find potential toxicity. Biomarkers enable go/no-go decisions during the drug development process.
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BIOANALYTICAL SERVICES Cell-Based Assays
Cell-based assays bridge the gap between in vitro evaluations and clinical outcomes and can be critical to the development of new therapies.
Regulatory agencies recognize the value of cell-based assays for potency determination and neutralizing antibody (NAb) assessment.
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BIOANALYTICAL SERVICES Consultancy Services
Consultancy services can assist in optimizing your study's assay strategy and enhancing submission success. Our team of experts has validated numerous assays and supported hundreds of studies, providing streamlined timelines and guidance throughout the project.
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