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INVESTIGATOR PROFILES

Paul G. Ambrose

DIRECTOR
 Institute for Clinical Pharmacodynamics,
Ordway Research Institute

SENIOR SCIENTIST
Ordway Research Institute

ASSOCIATE RESEARCH PROFESSOR
 School of Pharmacy and Pharmaceutical Sciences,
University at Buffalo

EDITOR
Antimicrobial Agents and Chemotherapy, American Society for Microbiology, Washington, D.C.

CONTACT
Institute for Clinical Pharmacodynamics
Phone: (518) 429-2600
Fax: (518) 429-2601
pambrose-ICPD
@ordwayresearch.org


Paul G. Ambrose, Pharm.D., F.I.D.S.A.

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 (CLSI, formally NCCLS) 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.

Finally, Dr. Ambrose is the author or coauthor of over 50 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.

Selected Publications View

  • Ambrose PG, Meagher AK, Passarell JA, Van Wart SA, Cirincione BB, Bhavnani SM, Ellis-Grosse E. Application of patient population-derived pharmacokinetic-pharmacodynamic relationships to tigecycline breakpoint determination for Staphylococci and Streptococci. Diagn Microbiol Infect Dis 2009; 63:155-159.
  • Passarell JA, Meagher AK, Liolios K, Cirincione BB, Van Wart SA, Babinchak T, Ellis‑Grosse EJ, Ambrose PG.  Exposure-response analyses of tigecycline efficacy in patients with complicated intra-abdominal infections. Antimicrob Agents Chemother 2008; 52:204-10.
  • Ambrose PG, Forrest A, Craig WA,  Rubino CM, Bhavnani SM, Drusano GL, Heine HS Pharmacokinetics-pharmacodynamics of gatifloxacin in a lethal murine-Bacillus anthracis inhalation infection model.  Antimicrob Agents Chemother 2007; 51:4351-5.
  • Meagher AK, Passarell JA, Cirincione BB, Van Wart SA, Liolios K, Babinchak T, Ellis‑Grosse EJ, and Ambrose PG.  Exposure-response analyses of tigecycline efficacy in patients with complicated skin and skin-structure infections.  Antimicrob Agents Chemother 2007; 51:1939-45.
  • Ambrose PG, Bhavnani SM, Rubino CM, Louie A, Gumbo T, Forrest A, Drusano GL. Pharmacokinetics-pharmacodynamics of antimicrobial therapy: It’s not just for mice anymore. Clin Infect Dis 2007; 44:79-86.
  • Booker BM, Smith PF, Forrest A, Bullock J, Kelchlin P, Bhavnani SM, Ambrose PG. Pharmacokinetic and Pharmacodynamic Characterization of Gatifloxacin Against Salmonella Typhi in an in vitro Infection Model. Antimicrobial Agents and Chemotherapy. 2005;49:1775-1781.
  • Ambrose PG, Anon JB, Owen JS, Van Wart S, McPhee ME, Bhavnani SM, Piedmonte M, Jones RN. Use of pharmacodynamic end points in the evaluation of gatifloxacin for the treatment of acute maxillary sinusitis. Clinical Infectious Diseases, 2004;38:1513-1520.
  • Ambrose PG, Bhavnani SM, Cirincione BB, Piedmonte M, Grasela TH. Gatifloxacin and the elderly: Rationale for a potential age-related dose reduction. Journal of Antimicrobial Chemotherapy, 2003;52:435-440.
  • Bhavnani SM, Hammel JP, Forest A, Jones RN, Ambrose PG. Relationships between patient- and institutional-specific variables and decreased antimicrobial susceptibility of gram-negative pathogens. Clinical Infectious Diseases, 2003;37:344-350.
  • Ambrose PG, Grasela DM, Grasela TH, Passarell J, Mayer HB, Pierce PF. Pharmacodynaics of fluoroquinolones against Streptococcus pneumoniae in patients with community-acquired respiratory tract infections. Antimicrobial Agents and Chemotherapy; 2001;45:2793-2797.
  • Dudley MN, Ambrose PG. Pharmacodynamics in the study of drug resistance and establishing in vitro susceptibility breakpoints: ready for prime time. Current Opinion in Microbiology, 2000;3:515-521.