What is Clinical Pharmacology?
Clinical Pharmacology at API is a dedicated approach to optimizing drug development. We combine scientific expertise, regulatory knowledge, and cutting-edge technologies to design and execute robust clinical pharmacology studies.
Key Focus Areas:
- Dosing Strategies: Develop optimized dosing strategies for enhanced therapeutic outcomes and reduced adverse effects.
- PK/PD Modeling: Utilize advanced pharmacokinetic/pharmacodynamic modeling to optimize the drug development process.
- Pharmacometrics: Identify and validate biomarkers to facilitate early-phase clinical development and personalized medicine approaches.
Benefits of Clinical Pharmacology
With our Clinical Pharmacology & Data team, you’ll be able to unlock the following benefits:
- Data-Driven Decision-Making: Make informed decisions based on comprehensive clinical pharmacology data, enhancing the probability of success in drug development.
- Accelerated Development: Streamline the drug development process by optimizing study designs and efficiently navigating regulatory requirements.
- Personalized Medicine: Tailor treatments to population-based needs through precision medicine approaches informed by population pharmacokinetics (popPK) insights.
- Risk Mitigation: Identify and mitigate potential risks early in the development process, ensuring a smoother path to regulatory approval.
- Cost Efficiency: Optimize resource allocation and minimize costs by strategically incorporating clinical pharmacology insights into development strategies.
- Regulatory Compliance: Navigate complex regulatory landscapes with confidence, supported by our expertise in regulatory compliance and submissions.
Clinical Pharmacology Team
Patrick Mayo
VP, Quantitative Solutions
Read bioabout Patrick Mayo Patrick Mayo
VP, Quantitative Solutions
Dr. Mayo has over 40 years experience as a hospital clinical pharmacist and clinical pharmacologist in the pharmaceutical industry. He has worked at numerous biotech and CRO organizations integrating quantitative clinical pharmacology (pharmacometrics) with systems pharmacology, bioinformatics, and large data machine learning analytics. He was the Director of Clinical Pharmacology for Isotechnika Pharma, the SVP Clinical Pharmacology and Analytics for Hepion Pharma, and is the founder of Cogitare Analytics. In addition to quantitative analyses, Dr. Mayo also utilizes natural language processing to analyze texts, from antiquity to modern social media platforms.
Micheal Guirguis
Director, Clinical Pharmacology & Data
Read bioabout Micheal Guirguis Micheal Guirguis
Director, Clinical Pharmacology & Data
Micheal has over 20 years of experience as a pharmacokineticist and pharmacovigalence expert. During his career Micheal has worked for Alberta Health Services, Covance, Abbott, and Alberta Blue Cross and is a sought-after consultant for Health Canada and industry alike.
Scott Campbell
Associate Director, Quantitative Solutions
Caroline Zhao
Quantitative Systems Pharmacologist
Morteza Hajihosseini
Biostatistician
Fernanda Talarico
Biostatistician
Want assistance with Clinical Pharmacology?
Let’s pave the way for safer, more effective pharmaceuticals together. Contact us to discuss how API’s Clinical Pharmacology services can elevate your drug development process.
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