PK/PD models

Basilea reports new data for ceftobiprole (Zevtera®) presented at US IDWeek Congress 2023

Retrieved on: 
Tuesday, October 17, 2023
Efficacy, Staphylococcus, Methicillin-resistant Staphylococcus aureus, Ambrose, Abstract, Treatment, Clinical, Circulatory system, MRSA, Biomedical Advanced Research and Development Authority, BARDA, Enterococcus faecalis, Infection, ASPR, MSSA, IDSA, Isolates, Laboratory, Liolios Xirolivaditis, Staphylococcus aureus, PK/PD models, SAB, ABSSSI, CABP, Bronchopneumonia, Administration for Strategic Preparedness and Response, Streptococcus pneumoniae, Prescription Drug User Fee Act, Duke University School of Medicine, Infectious Diseases Society of America, Randomness, Development, Administration, Safety, Patient, PDUFA, HHS, Pharmaceutical industry, Vaccine, Ceftobiprole, Litherland, Enterococcus, Allschwil, Streptococcus, Bloodstream infections

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.

Key Points: 
  • Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.
  • It also provides results of pharmacokinetic-pharmacodynamic modeling supporting the dosing regimens to treat severe bacterial infections from the successful clinical phase 3 studies.
  • Abstract #1946 – In Vitro Activity of Ceftobiprole against Staphylococcus aureus Bacteremia Isolates from the United States (2018–2020) – L. Duncan, M. Castanheira, J. I.
  • Smart, M. E. Jones, P. G. Ambrose, K. Litherland
    Abstract #2561 – Population Pharmacokinetic Analyses for Ceftobiprole Using Data from Phase 1 and 3 Studies – A. P. Cammarata, K. Litherland, M. C. Safir, S. M. Bhavnani, M. Saulay, J. I.

Trevena Announces Publication of OLINVYK Respiratory Physiology Study In ANESTHESIOLOGY

Retrieved on: 
Tuesday, February 14, 2023
Dizziness, Somnolence, Leiden University Medical Center, PK/PD models, Anesthesiology, Patient, Paper, Lightheadedness, Senior, CNS, Morphine, Male, Female, IV, Comparison, Nausea, Central nervous system, Hypoventilation, Trevena, Ventilation, Pharmaceutical industry

CHESTERBROOK, Pa., Feb. 14, 2023 (GLOBE NEWSWIRE) -- Trevena, Inc. (Nasdaq: TRVN), a biopharmaceutical company focused on the development and commercialization of novel medicines for patients with central nervous system (CNS) disorders, today announced the publication of OLINVYK data in the peer-reviewed journal Anesthesiology. The paper, entitled “Respiratory Effects of Biased Ligand Oliceridine in Older Volunteers: A Pharmacokinetic-Pharmacodynamic Comparison with Morphine” was published in collaboration with researchers at several prestigious institutions, including the Leiden University Medical Center in the Netherlands. A link to the paper can be found at https://www.trevena.com/publications.

Key Points: 
  • The paper summarizes the key findings of the four-arm, double-blind, randomized crossover study of eighteen 56- to 87-year-old male and female participants.
  • The intent of the study was to evaluate the difference between oliceridine and IV morphine as measured by the effect on ventilation.
  • The results of the study demonstrated that oliceridine and morphine differed in their pharmacodynamics with a more rapid onset and offset of respiratory depression for oliceridine and a smaller magnitude of respiratory depression over time.
  • These data may be relevant in the clinical care of elderly patients.”
    As with all opioids, serious, life-threatening, or fatal respiratory depression may occur in patients treated with OLINVYK as indicated in the boxed warning.

Parexel Announces Acquisition of Leading Pharmacology Modeling & Analytics Modeling Firm Model Answers

Retrieved on: 
Thursday, February 20, 2020
Pharmacokinetics, Articles, Health sciences, Health, Systems engineering, Modeling and simulation, Simulation, PAREXEL, Conceptual model, Scientific modelling, PK/PD models

Model Answers provides pharmacokinetic (PK) and pharmacodynamic (PD) modeling, simulation and analysis services to customers in the life sciences industry to help increase the likelihood of successful drug development.

Key Points: 
  • Model Answers provides pharmacokinetic (PK) and pharmacodynamic (PD) modeling, simulation and analysis services to customers in the life sciences industry to help increase the likelihood of successful drug development.
  • As part of the acquisition, the Model Answers highly specialized staff have joined Parexels growing Clinical Pharmacology, Modeling and Simulation team, bringing a proven approach to PK/PD modeling and customer collaboration.
  • Founded in 2005, Model Answers has extensive experience working across many therapeutic areas including oncology, neurology and rare diseases while also providing important access to the growing Asia/Pacific market.
  • Parexel will also leverage the proven Model Answers Process, including best practices and proprietary software solutions that support modeling and simulation.

Certara Launches Version 8.2 of Its Industry-Leading Phoenix PK/PD Modeling and Simulation Software for Drug Development

Retrieved on: 
Thursday, September 12, 2019
Technology, Clinical trials, Software, Biotechnology, Pharmaceutical, Health, Data management, Health sciences, Pharmaceutical sciences, Pharmacy, Life sciences, Pharmacokinetics, Pharmacodynamics, Simulation, Modeling and simulation, PK/PD models

Certara, the global model-informed drug development and decision support leader, today announced the launch of Phoenix 8.2 , the industry gold standard in pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation software for drug development.

Key Points: 
  • Certara, the global model-informed drug development and decision support leader, today announced the launch of Phoenix 8.2 , the industry gold standard in pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation software for drug development.
  • Phoenix is the most advanced and widely-used validated software for PK, PD, and toxicokinetic modeling and simulation worldwide.
  • As the industry leader in leveraging modeling and simulation to improve decision making throughout the drug development process, Certara works to continually enhance our products to meet clients current needs and anticipate their future requirements.
  • With Phoenix 8.2, users can now also access PK Submit and Certara Integral directly using Phoenix plug-ins.