Pharm/Tox Consulting

With scientific expertise in pharmacology and toxicology (pharm/tox), PPD can support the development of tailored preclinical plans. Responding directly to client needs, we offer consulting services and solutions a la carte or as part of an integrated program to:

• Support the intended dose, phase of development, and route and duration of treatment in the clinic
• Identify and address toxicology issues unique to the compound, indication or patient population
• Review and prepare the preclinical pharmacology and toxicology sections of regulatory submission and meeting packages

By working with clinical operations, product development and regulatory affairs, PPD can provide expanded services throughout the development program.

Toxicology Consulting

PPD’s toxicologists, certified by the American Board of Toxicology, develop and implement preclinical toxicology plans. In conjunction with our clinical project managers and monitors, we provide consulting for:

• Study design (in vivo models, regimen, dose selection, regulatory compliance)
• Safety issues, assessment and testing
• Toxicology study protocols
• Qualified good laboratory practice (GLP) testing facilities
• Placement and conduct of studies
• Preparation and review of pharm/tox and absorption, distribution, metabolism and excretion (ADME) data for regulatory submissions

Using our experience with a variety of compounds and targets, we can develop a plan that considers toxicity issues including:

• Rapid pharmacokinetic (PK) screens
• Primary pharmacology
• Safety pharmacology
• Acute and subacute toxicology
• Chronic toxicology
• Cytotoxicity
• Genotoxicology
• Reproductive toxicology
• Carcinogenicity, including use of alternative models

Pharmacokinetic Support

PPD’s pharm/tox consulting and pharmacokinetic groups work together to provide comprehensive and flexible PK support for preclinical drug development, including:

• cGLP preclinical and toxicokinetic (TK) analyses:
• A TK report ready for integration into your final toxicology report
• PK analyses from high-throughput in vivo absorption screens
• Pharmacokinetics for drug discovery absorption screens:
• Interpretation of data obtained from preclinical absorption screens
• In vivo PK modeling:
• Analyses of supportive ADME studies
• PK modeling of drug substances, new chemical entities, bioequivalency testing or new formulation testing in various species
• Data and GLP-compliant reports to support the investigational new drug (IND) application necessary for first-in-man studies or ongoing toxicology studies required to support new drug application (NDA) submissions

We work closely with experts at our bioanalytical lab for efficient bioanalysis of tox samples and with colleagues at our cGMP lab to confirm dosing solutions comply with regulations. Allometric scaling can also be added to in vivo PK modeling.