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 […]

Read More
Topics:

Pharmacokinetics of Oral Terbinafine in Adult Horses

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 the pharmacokinetics of terbinafine when administered per rectum in two different suspensions at 30 mg/kg to adult horses. Six healthy adult horses were included in this […]

Read More
Topics:

Vaccination Mitigates the Impact of PRRSv Infection on the Pharmacokinetics of Ceftiofur Crystalline-free Acid in Pigs

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 MLV) (n = 10), challenged with wild-type porcine reproductive and respiratory syndrome virus (PRRSv) VR-2385 (n = 10), or vaccinated with PRRS MLV and later challenged with wild-type PRRSv […]

Read More
Topics:

Estimation of Tulathromycin Depletion in Plasma and Milk after Subcutaneous Injection in Lactating Goats Using a Nonlinear Mixed-effects Pharmacokinetic Modeling Approach

BACKGROUND: Extra-label use of tulathromycin in lactating goats is common and may cause violative residues in milk. The objective of this study was to develop a nonlinear mixed-effects pharmacokinetic (NLME-PK) model to estimate tulathromycin depletion in plasma and milk of lactating goats. Eight lactating goats received two subcutaneous injections of 2.5 mg/kg tulathromycin 7 days apart; blood […]

Read More
Topics:

Certara’s Simcyp Division Awarded Modeling and Simulation Grant from the US FDA’s Office of Generic Drugs

PRINCETON, NJ – Oct. 19, 2016 – Certara announces that the Office of Generic Drugs (OGD), US Food and Drug Administration (FDA) has awarded it a multi-year research grant to create and validate a physiologically-based pharmacokinetic (PBPK) modeling and simulation framework that complements existing models within the Simcyp Population-based Simulator.

Read More
Topics:

A Study to Examine the Relationship Between Metritis Severity and Depletion of Oxytetracycline in Plasma and Milk after Intrauterine Infusion

Metritis is a frequent problem in postpartum dairy cows. Intrauterine therapy with the antimicrobial oxytetracycline (OTC) is often used, although this therapy has not been shown to be superior to systemic therapy. The objectives of this study were to (1) determine the plasma and milk concentrations of OTC following intrauterine infusion in postpartum dairy cows […]

Read More
Topics:

Using Model-based Meta-analysis to Improve Decision-making in Drug Development

Making the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into understanding that helps chart the course for investigational drugs?

Read More
Topics:

Phase 1 Study Assessing the Pharmacokinetic Profile and Safety of Avibactam in Patients with Renal Impairment

Avibactam is a non-β-lactam β-lactamase inhibitor intended for use as a fixed-dose combination with ceftazidime for the treatment of certain serious Gram-negative infections. As avibactam is primarily excreted unchanged in the urine, renal impairment may affect its pharmacokinetics. This Phase 1 study investigated the effect of renal impairment and hemodialysis on avibactam pharmacokinetics and safety. […]

Read More
Topics:
Learn More LinkedIn Twitter Facebook Email