Pharmacology and Toxicology

The toxicologists and study monitors at PPD are certified by the American Board of Toxicology and have experience in a variety of compounds and therapeutic areas. Our nonclinical resources are dedicated to getting the project to first-in-man studies. We place and monitor studies; obtain competitive bids with comparisons based on critical milestones; and design and review study protocols, considering dose selection, animal models, regimen, overall design and regulatory compliance.

PPD has expertise in the following areas (our toxicology services are non-GLP):

  • Primary and secondary pharmacology
  • General toxicology (acute, subacute, subchronic and chronic) 
  • Special toxicology
  • Genetic toxicology
  • Reproductive and developmental toxicology
  • Carcinogenicity, including the use of alternative models
  • Safety pharmacology
  • Absorption, distribution, metabolism and excretion (ADME) data  

Extensive Pharmacokinetic Support 

PPD provides comprehensive and flexible pharmacokinetic (PK) and toxicokinetic (TK) support of nonclinical drug development and has extensive scientific and regulatory experience in:

  • Toxicokinetic analyses integrated into toxicity study reports (non-GLP) 
  • Single-dose and repeat-dose PK studies 
  • PK and pharmacodynamic (PD) modeling 
  • Allometric scaling 
  • Rapid ADME screens (Caco-2, metabolite stability, protein binding and P450 enzyme inhibition) 
  • Analysis of drug-drug interactions 

Seamless Cooperation

With experience in small molecules and biologics used in various routes of administration, the nonclinical development team, along with our analytical labs, can:

  • Perform extractions, dose analysis and formulation design for nonclinical studies 
  • Develop and provide release testing following good manufacturing practices (GMPs) 
  • Provide stability studies for active pharmaceutical ingredients (APIs) and clinical supplies 
  • Help establish drug substance and drug product specifications 
  • Identify and manage contract manufacturing for drug substance and drug product  
  • Provide risk assessments of extractables/leachables 
  • Support manufacturing changes and devise strategies to support the identity and qualification of impurities/degradation products 
Get answers to questions about drug discovery and development.