Certara will participate in 12 presentations and poster sessions focusing on drug development and virtual bioequivalence
PRINCETON, NJ – Nov. 7, 2017 – Certara®, the global leader in model-informed drug development and regulatory science, today announced that it will be participating in 12 sessions at the 2017 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting. This conference will be held from November 12–15 at the San Diego Convention Center in San Diego, CA.
“Global biopharmaceutical companies and regulatory agencies are recognizing that modeling and simulation (M&S) can play a pivotal role both in supporting new drug applications and demonstrating bioequivalence for complex generics. The US FDA has awarded Certara two grants to develop physiologically-based pharmacokinetic (PBPK) M&S models to help meet those goals. The first model predicts how supersaturating orally-dosed drug products will behave in the human gastro-intestinal tract. The second model assesses the virtual bioequivalence of two topical drug formulations such as cream versus gel or the same formulation with a different pH, viscosity, or base,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD.
“Furthermore, FDA’s Center for Drug Evaluation and Research is using M&S to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. M&S mastery is a valuable skill that is in high demand. We are delighted to have this opportunity to share some of our latest findings with our peers,” Dr. Muniz added.
Certara will participate in the following sessions at this year’s meeting:
Monday, Nov. 13
- M6064: PBPK Model Development for Trazodone: Application to Pediatric Dose Projection – Alice Ke (contributing author)
- M6065: A Novel Approach to Predict Glomerular Filtration Rate from Pre-birth to Geriatric – Farzaneh Salem, Trevor Johnson, Amin Rostami-Hodjegan
Tuesday, Nov. 14
- Scientific Forum: In Vitro-In Vivo Extrapolation for Predicting Metabolic Clearance Incorporating Inter-Subject Variability – Masoud Jamei
- Scientific Forum: Quantitative Prediction of Gut Metabolism and Oral Bioavailability Incorporating Physiological Variability – Amin Rostami-Hodjegan
- T1071: Pharmacokinetics of Obeticholic Acid and Sources of Variability in Patients with Primary Biliary Cholangitis – Nathalie Gosselin, Thomas Peyret, JF Marier (contributing authors)
- T4078: Integration of Business Rules for Non-compartmental Analysis With Phoenix WinNonlin – Venkateswari Muthukrishnan, Linda Hughes, Shilpa Ramachandra, David Baker, Nathan Teuscher
- T4090: PBPK Modeling to Explore the Potential Role of Cytochrome P450 3A Enzyme in Colonic Drug Metabolism—Oxybutynin: A Case Study – Shriram Pathak, Sibylle Neuhoff, Ali Nimavardi, Iain Gardner, David Turner, Matthew Harwood
- T7115: Integration of Physicochemical Product Characteristics within a Mechanistic Dermal PBPK Model to Support Virtual Bioequivalence Evaluation of Topical Drug Products: A Case Study with Acyclovir Topical Creams – Nikunjkumar Patel, Frederico Martins, Masoud Jamei, Sebastian Polak
Wednesday, Nov. 15
- Symposium: Pediatric PBPK Model Development and Predictive Performance: Questions of Maturity – Trevor Johnson
- W2073: Quantitative Prediction of Dermal Drug Absorption using MPML-MechDermA Model: Relative Effects of Application Site on Rivastigmine Pharmacokinetics from a Transdermal Delivery System – Tariq Abdulla, Nikunjkumar Patel, Sebastian Polak, Frederico Martins, Amin Rostami-Hodjegan, Masoud Jamei
- W2087: Reference-scaled Average Bioequivalence Approach for Drugs with a Narrow Therapeutic Index Using Phoenix WinNonlin – Christopher Mehl, Ana Henry, Linda Hughes
- W4060: Development and Verification of PBPK Model for a Topical Cream Formulation of Trifarotene to Simulate Local and Systemic Exposure and Model Application to Simulate Potential CYP-mediated Drug-drug Interactions – Nikunjkumar Patel, Sibylle Neuhoff, Sebastian Polak
Further information about the AAPS Annual Meeting is available at https://annual.aapsmeeting.org.
Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies.
Ellen Leinfuss, 609-216-9586
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Lisa Osborne, 206-992-5245
Rana Healthcare Solutions