Wolfe Laboratories - DMPK Services

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

Plasma Stability

The stability of test compounds in plasma is an important parameter, which not only affects in vivo results, but also the bioanalytical assay strategy and design. Wolfe Laboratories offers plasma stability testing as part of its in vitro ADME services. Investigation of plasma stability should be performed early in the discovery process in order to assess potential degradation and/or protein binding issues.

A solution of test compound in plasma is prepared and incubated for a predetermined time period at physiological temperature. Aliquots are removed at pre-defined time points and analyzed by LC-MS/MS. The peak area for the parent compound is compared to the time zero sample in order to assess the amount of compound still available and by direct correlation its stability in plasma. Plasma stability may be assessed in human and a variety of animal plasmas.