Using Pharmacokinetics to Assure Chemical Food Safety Blog Post
As a veterinarian, I’m responsible for the health and welfare of my animal patients. Sometimes, drugs are used to treat animals that are being raised for food (e.g., meat and…
How AI Tech Is Changing Regulatory Writing Blog Post
Did you know that you’re likely using artificial intelligence (AI) in your everyday life? For example, the digital music service, Spotify, creates “mood-based” playlists that are curated to users’ musical…
The Model-informed Precision Dosing Revolution Is Coming Blog Post
Modeling and simulation (M&S) has been widely accepted and adopted by biopharmaceutical companies and global regulatory agencies. However, its implementation in clinical care has been modest to date. Model-based approaches…
Navigating EMA Policy 0070—How Do We Ensure Compliance? Blog Post
Speaker Lora Killian provides insight on how EMA Policy 0070 will affect your organization and how to facilitate compliance, addressing many critical transparency and disclosure issues.
The Pharmacokinetics of Transdermal Flunixin Meglumine in Holstein Calves Blog Post
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…
Limitations of MIC as Sole Metric of Pharmacodynamic Response Across the Range of Antimicrobial Susceptibilities within a Single Bacterial Species Blog Post
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…
Pinnacle 21 Wins TOPRA Award for Regulatory Excellence in Innovation Blog Post
Certara’s Pinnacle 21 is honored to announce that Max Kanevsky, has been named to the PharmaVOICE 100 Class of 2015.
Pharmacokinetics of Oral Terbinafine in Adult Horses Blog Post
The primary study objective was to compare the pharmacokinetics of p.o. terbinafine alone to p.o. terbinafine administered with p.o. cimetidine in healthy adult horses. The second objective was to assess…
Vaccination Mitigates the Impact of PRRSv Infection on the Pharmacokinetics of Ceftiofur Crystalline-free Acid in Pigs Blog Post
The pharmacokinetics of intramuscularly administered ceftiofur crystalline-free acid (CCFA) were determined in pigs that were clinically healthy (n = 8), vaccinated with a Porcine reproductive and respiratory syndrome modified live virus (PRRS…
Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug Blog Post
Drug development is becoming more complex than ever. Regulatory agencies expect sponsors to consider a wide variety of intrinsic and extrinsic factors that could impact drug safety and efficacy. These…
