Month: 2017年11月
臨床薬理学のギャップ分析におけるベストプラクティス
Watch this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA.
Modeling and Simulation: Employing Virtual Patients to Advance Drug Development
Modeling and simulation can help guide critical decisions around dosing and toxicity, efficacy and mechanism of action, clinical trial design and cohort selection, and commercial probability of success as compared with existing therapies or others in development.
FDA Renews and Expands its Portfolio of Simcyp Simulator (PBPK) Licenses
PRINCETON, NJ – Nov. 14, 2017 – Certara today announced that the US Food and Drug Administration has greatly expanded its use of Certara’s PBPK Simcyp Population-based Simulator and its Pediatric and Cardiac Safety Simulators. Under the new agreement, FDA has almost tripled its number of licenses, equipping its M&S review team with almost 60 PBPK licenses.
Physiologically-based Pharmacokinetic (PBPK) Modeling to Explore the Potential Role of Cytochrome P450 3A Enzyme in Colonic Drug Metabolism—Oxybutynin: A Case Study
Quantitative Prediction of Dermal Drug Absorption Using MPML-MechDermA Model: Relative Effects of Application Site on Rivastigmine Pharmacokinetics from a Transdermal Delivery System
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
Phoenix WinNonlin を使用した、治療係数が小さい薬物 (Narrow The rapeutic Index Drug、NTID) における Reference-scaled Average Bioequivalence (RSABE) アプローチ
D360 Partner
D360 Partner is an affordable add-on product for D360 for external partners that allows for seamless, secure sharing of data and analysis while advancing communication and collaboration.
Certara to Showcase a Wide Range of Modeling and Simulation Advances at AAPS Annual Meeting
PRINCETON, NJ – Nov. 7, 2017 – Certara 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.
