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 toxicology 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

Read More About Pharmacokinetics, Pharmacodynamics and Toxicokinetics Testing

PBL Learning Center – Stages of Drug Development

PBL Learning Center – Preclinical Tests Timeline

PBL Case Study – In Vitro Drug Interaction Studies

 PBL’s Preclinical Toxicology Booklet
Download the free booklet

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