Year: 2016
Extending the Use of Antivirals to Treat Influenza in Infants
Certara scientists helped Roche apply an integrated clinical pharmacology program to support the development and global approval of Tamiflu for infants.
Phoenix IVIVC Toolkit
The Phoenix IVIVC Toolkit provides enhanced tools for in vitro-in vivo correlation studies used by formulation and pharmaceutical scientists to improve the success of BE studies. The IVIVC Toolkit approach requires less assumptions, as compared to other methods, and helps the user define the correlation observed from real in vivo profiles as compared to the dissolution profiles.
Changing the Drug Development Playbook – Model-informed Drug Development has Arrived
During the past few years, model-informed drug development (MIDD) has evolved from a research nicety to a regulatory necessity. Certara is committed to changing the game in drug development by fully leveraging MIDD across the development cycle.
Certara’s Simcyp Division Launches Quantitative Systems Toxicology Initiative
PRINCETON, NJ – Dec. 6, 2016 – Certara today announced that it is establishing a new Quantitative Systems Toxicology (QST) Initiative. That initiative, which will be managed by the company’s Simcyp division, leverages its Quantitative Systems Pharmacology (QSP) expertise.
Intravenous Topiramate: Pharmacokinetics in Dogs with Naturally Occurring Epilepsy
Certara Launches Phoenix WinNonlin Validation Suite Version 7.0
PRINCETON, NJ – Dec 7, 2016 – Certara today announced the launch of its Phoenix WinNonlin Validation Suite 7.0. This application simplifies and expedites the validation process for Phoenix WinNonlin software, which is used extensively for drug regulatory submissions.
The Pharmacokinetics of Transdermal Flunixin Meglumine in Holstein Calves
This study describes the pharmacokinetics of topical and intravenous (IV) flunixin meglumine in Holstein calves. Eight male Holsteins calves, aged 6 to 8 weeks, were administered flunixin at a dose of 2.2 mg/kg intravenously. Following a 10-day washout period, calves were dosed with flunixin at 3.33 mg/kg topically (transdermal). Blood samples were collected at predetermined times from 0 … Continued
Limitations of MIC as Sole Metric of Pharmacodynamic Response Across the Range of Antimicrobial Susceptibilities within a Single Bacterial Species
The minimum inhibitory concentration (MIC) of an antimicrobial drug for a bacterial pathogen is used as a measure of the bacterial susceptibility to the drug. However, relationships between the antimicrobial concentration, bacterial susceptibility, and the pharmacodynamic (PD) inhibitory effect on the bacterial population are more complex. The relationships can be captured by multi-parameter models such … Continued
