Pharmacology

Optimizing drug behavior and dosing

Drug Metabolism & Kinetics

Our pharmacology program provides comprehensive PK/PD analysis, drug-drug interaction studies, and dose optimization research to support drug development programs.

Services

Pharmacokinetic studies
Pharmacodynamic assessments
Drug-drug interaction trials
Food effect studies
Bioavailability and bioequivalence
Population PK modeling

Foundational Drug Categories & Technologies

Drug Modalities

Small Molecules: Traditional, chemically synthesized drugs (typically oral tablets) with molecular weight under 900 Da, capable of crossing cell membranes to reach intracellular targets. The foundation of pharmacology.

Biologics: Large, complex medicines derived from living organisms, including monoclonal antibodies (mAbs), therapeutic proteins, enzymes, and hormones. Require injection/infusion and target extracellular mechanisms.

Biosimilars: Highly similar versions of approved biologics, analogous to generics for small molecules but requiring extensive comparability studies due to biological complexity.

Targeted Therapy Classes

Kinase Inhibitors: Small molecules blocking specific kinase enzymes involved in cell signaling, particularly effective in cancer (e.g., EGFR, ALK, BCR-ABL inhibitors).

Monoclonal Antibodies (mAbs): Engineered antibodies targeting specific proteins with high specificity, used across oncology, immunology, and infectious diseases. Formats include IgG, bispecifics, and antibody-drug conjugates (ADCs).

Checkpoint Inhibitors: Immunotherapy antibodies blocking immune checkpoints (PD-1, PD-L1, CTLA-4) to unleash T-cell responses against cancer.

ADME & PK/PD Analysis

ADME: Comprehensive characterization of drug Absorption, Distribution, Metabolism, and Excretion profiles.
Pharmacokinetics (PK): Quantifying drug concentration over time to determine half-life, clearance, and optimal dosing.
Pharmacodynamics (PD): Measuring drug effects on the body, linking exposure to therapeutic and adverse responses.
Bioanalytical Methods: LC-MS/MS and immunoassays for precise drug and biomarker quantification in biological matrices.

Analytical Expertise

We employ advanced analytical methods including LC-MS/MS, biomarker analysis, and modeling & simulation to characterize drug behavior and optimize dosing regimens.

Integrated Research Excellence

Pharmacology studies form the scientific backbone of drug development, supported by specialized services. Clinical Trials Management conducts precisely controlled PK/PD studies with rigorous sample timing and chain of custody protocols. Data Management manages complex pharmacokinetic concentration-time data with validated bioanalytical results. Biostatistics performs sophisticated population PK modeling, exposure-response analysis, and dose optimization studies. Regulatory Affairs ensures clinical pharmacology packages meet global regulatory requirements for drug-drug interactions and special populations. Quality Assurance validates bioanalytical methods, and Medical Writing crafts detailed clinical pharmacology summaries for regulatory dossiers.