Taking Drug Development into the Virtual World
In her series of profiles of bioinformatics companies, Sophia Ktori looks at the work of biosimulation specialist, Certara.
Month: April 2016
Integrating Regulatory Writing and Modeling and Simulation into the Drug Development Process
This approach is not just a decision-making aid to reduce cost and time, but an ethical imperative to optimize the number of subjects exposed to new therapies.
Engaging the Public in the Clinical Research Process
The issue of transparency and disclosure of clinical trial data has been growing in importance over the past few years. Clinical trials are essential to developing new therapies for patients. But the individuals that participate in those trial put themselves at risk. In return, the medical community has an ethical obligation to disclose clinical trials … Continued
Streamline CDISC Electronic Data Submissions: Technology Solution for CDISC PK Study Data
Through our collaborations with regulatory agencies, and partnerships with major global nonprofits, we, at Certara, continuously strive to provide up-to-date solutions to help streamline the drug development process for our clients. Beginning at the end of 2016, in a continuing effort towards international harmonization across regulatory agencies, the US Food and Drug Administration (FDA), the … Continued
QRPEM – A New Standard of Accuracy, Precision, and Efficiency in NLME Population PK/PD Methods
Summary: A new accurate likelihood EM estimation method QRPEM (Quasi-random Parametric Expectation Maximization) has been introduced in the current release of Phoenix NLME. The method belongs to the same general class of parametric EM methods as IMPEM in NONMEM 7, MCPEM in S-ADAPT, and SAEM in MONOLIX, S-ADAPT, and NONMEM 7. The QRPEM method is … Continued
Model-based Drug Development for Generic Products
As a generic drug manufacturer, the goal of your product development program is to demonstrate bioequivalence of your product to the branded product. Often a straight-forward trial and error process based on the experience of the formulation team has been successful. As innovators plan ahead to protect their product lines, however, they have made this … Continued
Introducing Population Pharmacokinetic Analysis Into Your Early Drug Development Efforts
Population pharmacokinetic analysis has become a key tool for Clinical Pharmacology experts when working with data from human subjects. In the recent past, new drug registrations utilized pharmacokinetic information from healthy volunteers, in whom intensive PK sampling could be performed. In an effort to examine possible dosage adjustments for patients or other subgroups (e.g. elderly, … Continued
Choosing the Right Software for PK/PD Analysis
The methods used to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of a compound can be inherently complex and sophisticated. PK/PD analysis is a science that requires a mathematical and statistical background, combined with an understanding of biology, pharmacology, and physiology. PK/PD analysis guides critical decisions in drug development, such as optimizing the dose, frequency … Continued
Return on Investment of a Compliant Clinical Data Repository
An accelerating pipeline of drug candidates is emerging from discovery, waiting for efficient and fast evaluation of their pharmacokinetics before they can be pushed through to the next stages of drug development. The ever increasing cost of clinical studies is forcing more elaborate and intensive evaluations of pharmacokinetic (PK) and pharmacodynamic (PD) characteristics at earlier … Continued
Drug Development and Label Optimization Using Proven Modeling and Simulation Methodology
The approved drug label is the official description of a drug product and includes what the drug is used for, who should take it, side effects, instructions for use, and safety information for clinicians and patients. For drug companies, the label is the culmination of years of work and millions, if not billions of dollars. … Continued