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Month: March 2015

Modeling and Simulation to Support Phase 2 Dose Selection for RG7652, a Fully Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9

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RG7652 is a fully humanized monoclonal antibody targeting human PCSK9, a regulator of serum low density lipoprotein cholesterol (LDLc) levels. RG7652 prevents degradation of the hepatic LDLc receptors by blocking PCSK9 binding and thereby resulting in efficient LDLc uptake by hepatocytes. The pharmacokinetics of RG7652 have been evaluated in healthy subjects after single and multiple … Continued

How to Use Phoenix RSABE Templates

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Traditional average bioequivalence (ABE) methodology requires prohibitively large sample sizes when used with highly variable drugs and drug products (HVDs/HVDPs), which are defined as products with intra-subject CV% of the reference greater than 30%. This increases the expense of BE studies, places more study subjects at risk, and ultimately limits the availability of generics. Reference-scaled … Continued

Improve Your Success Rate in Costly Bioequivalence Studies with IVIVC

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Did you know that 84% of the 4 billion prescriptions written each year are for generic drugs? Clearly, generics are a big business. Regulatory agencies, such as the FDA, require generic drug manufacturers to show that generic drugs are bioequivalent to the reference drug. Bioequivalence (BE) studies can also be required for pharmaceutical variations made … Continued

Certara Supported Risk Assessment Research Wins Outstanding Paper Award

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Authored by The Hamner Institutes for Health Sciences, the EPA, and Certara, this award-winning paper uses high-throughput toxicity testing to compare susceptibility between populations PRINCETON, NJ – Mar. 27, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that the Toxicological Sciences article, entitled “Incorporating Population Variability and … Continued

Safety and Pharmacokinetics of Single and Multiple Ascending Doses of Avibactam Alone and in Combination with Ceftazidime in Healthy Male Volunteers: Results of Two Randomized, Placebo-controlled Studies

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Avibactam is a novel non-β-lactam β-lactamase inhibitor effective against Ambler class A, C and some class D β-lactamases that is currently in clinical development in combination with ceftazidime for the treatment of serious Gram-negative infections. It restores the in vitro activity of a range of β-lactams, including ceftazidime, against extended-spectrum β-lactamase-producing pathogens. Two phase I … Continued

How Do We Translate Pre-clinical and Clinical Research into Drug Labeling?

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The number of submissions to the FDA involving physiologically-based pharmacokinetic (PBPK) modeling has increased significantly over the past few years. PBPK modeling can be applied in drug discovery and development from the early stages prior to lead development where limited data are available as well as in early to late drug development. There are now … Continued

Personalized Toxicology: A New Paradigm for Chemical Risk Assessment

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Historically, toxicity testing has been conducted by giving lab animals high doses of chemicals and observing them for adverse events. But quantifying the risks chemicals pose to humans based on animal studies is problematic as the chemical doses are often orders of magnitude higher than environmental levels. Moreover, this process is slow, expensive, and ethically … Continued

Aaron Bernstein Appointed to Group Updating Guidelines on Clinical Study Protocols and Reports

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Dr. Bernstein will work with the Budapest Working Group to update International Conference on Harmonisation guidelines for developing clinical study protocols and reports PRINCETON, NJ – Mar. 19, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that Aaron Bernstein, Ph.D., director of global submissions for Synchrogenix, its … Continued

Certara Opens Larger Corporate Headquarters in Princeton, NJ

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Company plans to expand its executive, business development, science, sales, and marketing teams PRINCETON, NJ – Mar. 17, 2015 – Certara®, the global biosimulation technology-enabled drug development and drug safety consulting company, today announced that as a result of its rapid growth, the company is moving its corporate headquarters to a larger location in Princeton, … Continued

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