Paul G. Ambrose , Pharm.D., FIDSA

Director, ICPD · Ordway Research Institute
Adjunct Associate Research Professor, School of Pharmacy and Pharmaceutical Sciences, University at Buffalo
Editor, Antimicrobial Agents and Chemotherapy

Telephone: (518) 429-2600
Fax: (518) 429-2601

E-mail: PAmbrose-ICPD@OrdwayResearch.org

Research Focus

Dr. Ambrose’s areas of scientific inquiry primarily involve anti-infective translational science, with the goal of improving patient care through the application of pharmacokinetic-pharmacodynamic (PK-PD) principles. Knowledge gained though the use of non-clinical (in vitro and animal) PK-PD infection models may be leveraged with human pharmacokinetic data in order to discriminate between potential dosing regimens and thereby increase the probability of positive clinical outcomes while minimizing the potential for drug-related toxicities. We have successfully utilized this approach for regulatory decision-making and as support for Clinical and Laboratory Standards Institute susceptibility breakpoint determinations.

Our team’s expertise ranges from the microbiology laboratory, with in vitro PK-PD infection models, to the animal laboratory for PK-PD studies, through the Phase 1 Unit for healthy-volunteer and patient studies, into Phase 2 through 4 clinical trial design, to pharmacokinetic and PK-PD mathematical analyses to support regulatory and commercial efforts. More specifically, our team’s mathematical expertise includes pharmacokinetic and population pharmacokinetic modeling, PK-PD analyses, Monte Carlo simulation, and epidemiological analyses of drug use and antimicrobial resistance.

We are interested in novel PK-PD-based clinical trial design, which serve to better describe the time-course of drug effect. The use of PK-PD-based clinical trial endpoints can have a significant impact on sample size power calculations and thereby hold the promise of reducing the total number of patients required to demonstrate therapeutic efficacy.

Dr. Ambrose is the author of over 60 peer-reviewed scientific publications and approximately 100 scientific abstracts. Dr. Ambrose has served as an Editor for four textbooks, most notable the 1st and 2nd Editions of Antimicrobial Pharmacodynamics in Theory and Clinical Practice.