Wolfe Laboratories - Pharmacokinetic Analysis

In-vitro ADME Screens
  Aqueous Solubility
  Plasma Stability
  Protein Binding
  Microsome Stability
  CYP450
  Permeability
Pharmacokinetic Analysis
  Bioanalytical Method Development
  Biological Fluid Sample Analysis
  Tissue Analysis
Metabolite Identification

>	CASE STUDY 1 Advancement of an Early Development Candidate to Phase IIb Trials
>	CASE STUDY 2 Development of a Parenteral Formulation of a Cytotoxic Natural Product
>	CASE STUDY 3 Oral Formulation Development for Proof-of-Concept Animal Toxicology Studies
>	CASE STUDY 4 cGMP Analytical Release Testing of a Cytotoxic Drug, as Well as Other Analytical and Bioanalytical Services
>	CASE STUDY 5 Parenteral Dosage Form Development of a Highly Insoluble Molecule

Bioanalytical Method Development

As part of our bioanalysis and pharmacokinetic services, Wolfe Laboratories develops highly sensitive and robust LC-MS/MS methods to measure the levels of small molecule and protein therapeutics in all types of body fluids and tissues from a variety of species, including rodents, canines, primates, and humans. We also optimize existing methods to improve sensitivity and selectivity (e.g., reduce the LLOQ, improve S/N, enhance the extraction procedure, etc.). Various levels of development and qualification are available, from early discovery to GLP validation for IND-enabling and clinical studies, depending on the needs of the program.