PK/PD Modeling & Simulation

Improve Your Success Rate in Costly Bioequivalence Studies with IVIVC

Ana Henry

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 […]

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Topics: PK/PD Modeling & Simulation

Personalized Toxicology: A New Paradigm for Chemical Risk Assessment

Masoud Jamei

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 […]

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Topics: PBPK Modeling & Simulation

5 Certara Posters You Should Have Seen at ASCPT 2015

Amin Rostami

I attended and contributed to the recent annual meeting of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) in New Orleans. This is a meeting that I have attended regularly in the past. It was a valuable opportunity to see some truly innovative scientific approaches to the toughest challenges in drug development. If I […]

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Topics: PBPK Modeling & Simulation

Heartbreaking Works of Staggering Genius: Cardiac Safety for Oncology

Michael Eckstut

I could give you some of facts and figures about cancer. Like the fact that the American Cancer Society estimates there will be 1,658,370 new cancer cases diagnosed and 589,430 cancer deaths in the US this year. Or that pancreatic cancer has only a 5-year survival rate of 5%. But, these statistics belie the heartbreaking reality […]

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Topics: PK/PD Modeling & Simulation

Predicting mAb Pharmacokinetics in Humans with a Minimal PBPK Model

Iain Gardner

Monoclonal antibodies (mAbs) and their derivatives are a rapidly growing segment of the pharmaceutical industry’s pipeline. In fact, more than 40 mAbs and derivatives have been approved for a variety of therapeutic applications; around 500 mAbs and derivatives are currently in different stages of development. Monoclonal antibodies have pharmacokinetic (PK) properties that are quite distinct from that […]

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Topics: PBPK Modeling & Simulation
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