PK/TK Consulting Support

The applied science fields of pharmacokinetics, toxicokinetics, pharmacodynamics, clinical pharmacology, and bioanalytical sciences are inextricably connected and are core areas of expertise for our consultants. Successful development and commercialization of today’s biotechnology and conventional drugs requires the careful planning, execution and analysis of a series of toxicology studies during preclinical evaluation and clinical pharmacology studies conducted in phase I to phase IV. Data from such investigations take a prominent place in product labeling, provide an underpinning for the mechanism of action, establish vital exposure-response relationships, and define dosing requirements in different populations. At the heart of all these studies are robust validated bioanalytical measurements of the drug substance in animal or human tissues and the application of state-of-the-art pharmacokinetic or pharmacodynamic analyses using specific models to assess and summarize the important findings. The efficiency of drug development can be increased by leveraging PK/PD analyses to understand complex dose-exposure-response time relationships.

Our consultants can help develop innovative strategies for implementing decisive studies that enhance the toxicological and clinical pharmacological evaluation of drugs leading to commercial success. These services include:

• Non-GLP or GLP toxicokinetic evaluation for toxicology or ADME studies
• Exposure-dose-response relationships
• Accumulation and linearity assessment
• Individual animal or pooled data analyses – protocol specified analyses
• PK evaluation of phase I-IV clinical pharmacology and efficacy/safety studies
• Bioavailability, bioequivalence, drug interaction, and special population studies