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IND-enabling Preclinical Studies

Abstract 3d cells

Drug Metabolism and Pharmacokinetics (DMPK)

DMPK is at the heart of translating new science into medicine. The science of DMPK has been advanced through understanding and use of biomarkers, histopathology, humanized-animal models, computational biology, and in silico predictive models. Omar Consulting Group helps clients to use these tools to bridge the gap between the bench and the bedside.

Putting test tubes

Chemistry, Manufacturing and Control (CMC)

Chemistry, manufacturing, and control information is needed to assure product safety, identity, quality, purity, and strength (including potency) of an investigational product. The FDA requires all sponsors of investigational new drug products, including investigational gene therapy products, to describe the CMC information for the drug substance and the drug product. Omar Consultants have experience in designing CMC for drugs and biologics.

experimental mouse

Small Animal Testing

Numerous conceptual and methodological issues can obstruct the translation of preclinical results to clinical practice, including:

  • the choice of the wrong tools and animal models
  • having inadequate tools and models
  • asking the wrong questions
  • poor design and under-powering of animal studies
  • testing the wrong hypothesis in an animal model

Omar Consulting will help build a collaborative approach to selecting the correct small animal for testing.

Young Chimpanzee

Nonhuman Primates

Experiments in large animal models such as nonhuman primates can be expensive. In some cases they are not even needed. Omar Consulting can help you recognize those instances when studies in primates are futile. When an NHP is needed, Omar Consulting can help your design better and more effective large animal studies.