Pharmacokinetic, Pharmacodynamic and Toxicokinetic Studies

Non-clinical Pharmacokinetic (PK) and toxicokinetic (TK) analyses are key activities of early drug development. These studies can be exploratory, or can be more extensive and formalized requiring GLP compliance. Thoroughly understanding the DMPK of a potential clinical candidate can have a huge impact on the success of a drug discovery program.

PK and TK studies provide useful and required information that informs no effect levels (NOEL), human equivalent doses (HED), and pharmacokinetic/pharmacodynamic (PK/PD) drivers. Carrying out PK studies enables the determination of PK parameters such as AUC, clearance, volume of distribution, half-life, Cmax, and Cmin.

Non-Clinical PK/PD Bioanalysis

Pacific BioLabs’ integrated in vivo science and bioanalytical services can seamlessly perform in vivo sample generation as well as bioanalysis. PBL can conduct PK, PD and/or TK studies in most rodent species, and has the instrumentation and expertise in its bioanalytical lab to provide rapid and sensitive drug concentration determinations from a variety of matrices.

PBL has experience working with many biomatrices, and extraction conditions will be optimized to provide reproducible and robust methods. Exploratory PK with bioanalysis can be implemented simultaneously and completed rapidly in many cases. For GLP compliant TK studies PBL provides the technical and regulatory (QA) expertise to ensure method validation protocols, validation reports and analytical standard operating procedures (SOPs) are all in compliance with current GLP requirements.

PK, PD and TK Bioanalytical Lab Services

Pharmacokinetics (PK) Studies
PK Sample Analysis
Toxicokinetics (TK) Studies
Metabolite Identification and Profiling
Rapid PK Screening
Mass Balance
Tissue Distribution
Bioequivalence (formulation support)
MSD-ECLA (Meso Scale Discovery) Assays
ELISA Assays

PK, PD and TK Available Species

Mouse
Rat
Rabbit
Guinea Pig

PK, PD and TK Routes of Administration

Oral (PO)
Subcutaneous (SC)
Intravenous (IV)
Intramuscular (IM)
Intraperitoneal (IP)
Topical

Collection

Whole blood
Serum
Plasma
Urine
Feces
Tissue

Dosing Regimen

Single dose
Repeat dose
Cassette Dosing

PK, PD and TK Studies