Nonclinical

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Early Drug Development and Candidate Selection

Evaluation of candidate molecules can involve considerations from multiple functional areas. Pacific BioDevelopment assists our clients in making these evaluations by bringing expertise in the following areas:

• Process development and manufacturing issues
• Toxicology and immunology
• Efficacy in animal models
• Pharmacokinetics and pharmacodynamics

Pharmacology and Pharmacokinetics

Pharmacology and Pharmacokinetics services include study design, conduct, data analysis, report writing and submissions. Here are some of the services Pacific BioDevelopment offers in this arena:

• Strategic development and implementation of Phase-appropriate non-clinical absorption, distribution, metabolism, and excretion (ADME) development programs in concert with the toxicology program
• Design, oversee, and analyze data for clinical and non-clinical pharmacokinetic studies
• Prepare for and/or participate in FDA meetings
• Optimize clinical dose selection using pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) modeling data
• Due diligence for in-licensing opportunities
• Draft and/or review reports and ADME sections for regulatory submissions
• Provide interim management and oversight for clients without internal staff
• Assay support and troubleshooting

Toxicology

Toxicology services include the strategic planning, design, implementation, monitoring and reporting of toxicological studies. Here are some of the services Pacific BioDevelopment offers in this arena:

• Strategic development and implementation of Phase-appropriate non-clinical programs
• Development of oral and written regulatory correspondence
• Selection and oversight of laboratory resources
• Draft and/or review internal non-clinical safety reports
• Draft and/or review of non-clinical toxicology sections for regulatory submissions (U.S. and International)
• Due diligence for in-license opportunities
• Prepare for and participate in FDA meetings
• Good Laboratory Practices (cGLP) and study monitor training
• Provide interim management and oversight for clients without internal staff
• Risk Assessment related to impurity issues or cross contamination