Bedard ADME-Tox Solutions

Providing expertise in nonclinical pharmacokinetics and toxicology
to small biotech and pharma companies.

Leanne L. Bedard, PhD, RAC, DABT, provides consulting services in nonclinical drug metabolism, pharmacokinetics, toxicology and regulatory affairs to solve the most challenging problems arising in drug discovery and development.

Providing solutions to challenges in drug discovery and development

  • Problem-solving of absorption, distribution, metabolism and excretion (ADME) and toxicology issues in lead compounds and series in drug discovery
  • Design and data interpretation of nonclinical ADME, pharmacokinetic/toxicokinetic, and toxicology studies
  • Projections of human pharmacokinetic parameters based on nonclinical data
  • Projections of human efficacious dose based on nonclinical pharmacokinetics and pharmacodynamics
  • Risk assessment of drug-drug interaction potential using mathematical models
  • Preparation and/or review of nonclinical pharmacokinetic and toxicology sections for regulatory submissions
  • Messaging of study findings for communication to regulatory authorities
  • Interfacing/interacting with regulatory authorities for filings in jurisdictions worldwide
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