Pharmacodynamics

Naïve, protein-naïve and non-naïve study subjects with potential distinct genetic, clinical and immunological phenotypes.

Exploratory and confirmatory biomarker validation study designs.

Organ-specific or complete histology and pathology evaluation.

Cellular, histologic and immunologic phenotyping (immuno-assays, immunopharmacology and flow cytometry).

Concurrent standard pharmacokinetic or dedicated study designs.

Genetic, small molecule and protein-based biomarkers.

Tissue-specific efficacy biomarker levels by biosampling, biopsy or microdialysis.

Information
Assess systemic biomarker level during standard or non-standard pharmacokinetic

Protocol
The biomarker levels are measured in the systemic circulation during the conduct of a standard or specialized pharmacokinetic study.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, biomarker levels are analyzed and a full report generated.

Information
Assess systemic biomarker level using a dedicated experimental design

Protocol
The biomarker levels are measured in the systemic circulation during the conduct of a especialy designed study.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, biomarker levels are analyzed and a full report generated.

Information
Assess the systemic levels of specific clinical efficacy and safety biomarkers

Protocol
Specific clinical efficacy and safety biomarkers levels are measured by multiplex assays in the systemic circulation during the conduct of a standard or specialized pharmacokinetic study.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples are sent to the sponsor for compound analysis (DAS: dose-and-ship). Specific biomarker levels are analyzed and a full report generated.

Information
Assess tissue specific or systemic biomarker level using a confirmatory clinical design

Protocol
The biomarker levels are measured in the systemic circulation or in the different tissues during the conduct of a study designed to assess clinical pharmacology or toxicology.

Delivery
Blood, plasma, serum or DBS (dried blood spot) samples or tissue samples or tissue extracts are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, biomarker levels are analyzed and a full report generated.

Information
Assess tissue biomarker level during standard or non-standard pharmacokinetic

Protocol
The biomarker levels are measured in specific tissues and fluids by biopsies or microdialysis during the conduct of a standard or specialized pharmacokinetic study.

Delivery
Tissue samples or tissue extracts are sent to the sponsor for analysis (DAS: dose-and-ship). Alternatively, biomarker levels are analyzed and a full report generated.

Information
Assess the effect of test compound or protein on physiological markers

Protocol
The physiological markers are measured during a concurrent or stand-alone pharmacodynamic study. Typical markers are cardio-vascular, neurological, endocrine, muscular, renal and respiratory.

Delivery
Physiological markers are analyzed and a full report is generated.

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