Quantify AD Clinical Outcomes Database
The current version of the database includes clinical safety and efficacy information on all symptomatic drugs as well as newer Abeta drugs currently approved or in development for Alzheimer Disease (AD).
Tag: Central Nervous System
Certara’s Best of Blogs 2016
A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
Intravenous Topiramate: Pharmacokinetics in Dogs with Naturally Occurring Epilepsy
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
A Randomized Dose Escalation Study of Intravenous Baclofen in Healthy Volunteers: Clinical Tolerance and Pharmacokinetics
Modeling and Simulation Guides Dosing for a New Anti-psychotic Drug
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 factors include intrinsic variability― CYP metabolizer status, age, sex, renal/hepatic impairment― as well as external variables― co-medications, food effects, smoker status, etc. Clinical trials alone … Continued
Drug Development through Modeling and Simulation – the Business Case
The new blockbuster: well-defined patient populations bring efficiency to drug development and higher commercial value to precision drugs (labels).
How Model-based Approaches Can Improve Precision Dosing in Clinical Care
In this webinar, Dr. Adam Darwich, Certara Lecturer in Precision Dosing at the Manchester Pharmacy School at The University of Manchester, presented several case studies that illustrate how PBPK models have been used to predict drug-drug interactions, extrapolate to special populations, and optimize clinical study design.
Modeling and Simulation Supports Dosing Guidelines for a Novel Treatment for Schizophrenia
A medium-sized biopharmaceutical company leveraged Certara’s trial simulation software and PBPK modeling and simulation consulting services to facilitate regulatory approval for a long- acting injectable antipsychotic drug.
Quantify Depression Clinical Outcomes Database
The Quantify Major Depression Disorder (MDD) Clinical Outcomes Database documents clinical efficacy and safety information from randomized and controlled regulatory trials investigating monotherapy and adjunctive therapy pharmaceutical drugs for major depression disorder and treatment-resistant depression.