Pharmacokinetics (PK) Study: Drug Concentration vs. Time in the Body A pharmacokinetic study provides the basis for determining drug exposures...
Nonclinical and In Vivo Toxicology (Tox) Studies: Primary Safety and Toxicity Evaluation for your IND Submission Nonclinical Toxicology (tox) Studies...
Bioequivalence and Bioavailability: Measuring and Comparing Systematic Drug Circulation Bioavailability of drugs is the concentration of the drug compound that...
PK PD Analysis Study: Foundation of your eCTD FDA Submission PK PD analysis study links drug exposure to therapeutic effect...
Dose Formulation Analysis: Testing Concentration, Specificity, Homogeneity, and Stability Dose formulation analysis is performed to assess test article concentration, formulation...
Drug Metabolism and Pharmacokinetics (DMPK): Understanding Dosage, Toxicity, and Therapeutic Index Drug metabolism and pharmacokinetics, or commonly referred to as...
ADME Studies: Measuring Drug Viability and Suitability for Later Development The absorption, distribution, metabolism, and excretion (ADME) pharmacokinetics studies form an efficacy...
Immunogenicity Testing: Immune Responses Affecting Drug Safety & Efficacy Immunogenicity testing plays a crucial role in measuring the immune response...
Biomarker Testing and Analysis: Quantitate Biological/Pathogenic Processes or Pharmacologic Response to Therapy in the Body Biomarker testing services provide a...
Biomarker research, discovery, and qualification are pivotal in modern drug development from demonstrating proof-of-concept (POC) to establishing drug safety and...
Bioanalytical Assay Development and Validation: Reproducible and Reliable Quantitation of Analytes Bioanalytical assay development helps determine the design implications, limitations,...
Biochemical Assays: Quantify Cellular Processes and Metabolic Reactions Biochemical assays are analytical methods used to measure and quantify metabolic reactions and...
Mechanism of Action (MOA) Studies: Understanding Molecular Targets and Identifying Proteins plus Activated Pathways The mechanism of action of a...
Cell-based Assays: Understanding Sub-cellular Localization and Pathways Contrary to biochemical assays that analyze the cell lysate, Cell based assays measure...
Cytotoxicity Assay: Evaluating Drug Safety and Cell Proliferation Cytotoxicity assays are developed to analyze the ability of certain drug compounds...
