Opportunities in Preclinical Development

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IDBS EWB Suite CMYK 1 THE E-WORKBOOK CLOUD

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Preclinical development is the combination of numerous specific scientific domains. It often encompasses:

  • Pharmacology (PD – both in-vitro e.g. plate-based and in-vivo e.g. in life)
  • Drug metabolism (what happens to the drug when it is metabolized in the body
  • Pharmacokinetics (PK – what happens to the drug when in the body, where it goes and at what concentration for how long
  • Bioanalysis (specific analytical techniques used to estimate the drug concentration and metabolite concentration in specific tissues)
  • Formulations (how best to take the API and formulate this into a drug product (a pill, injectable, inhaled aerosol) and
  • Safety/toxicology (analysis of the effects of the drug on specific organs and safety concerns e.g. cardiac safety, liver toxicity, etc.)

 

When it comes to informatics and data management, each of these domains is characterized by specific requirements due to their diverse scientific needs, and in this whitepaper we explore these critical elements.

 

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