Regulatory & Medical Writing

Do the Right Thing: Ethical Mandates for Clinical Trial Transparency

Kelley Kendle

The history of biomedical research in the United States has long been plagued with ethical problems. Writer Rebecca Skloot details a famous example of this history in her book, “The Immortal Life of Henrietta Lacks.” The non-fiction work recounts the origin of the HeLa cells—derived from the tumor of a Baltimore woman named Henrietta Lacks. […]

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Topics: Regulatory & Medical Writing

Pediatric Drug Dosing: Tackling Big Problems for Little Patients

Nastya Kassir

The challenges and complexities of pediatric drug development are well recognized. Pharmacometric modeling and simulation (M&S) leverages prior knowledge to support pediatric drug dosing, trial design and regulatory writing for submissions. As the benefits of pharmacometrics for drug development and regulatory decision-making become increasingly well documented, the FDA has challenged the industry to more rigorously apply […]

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Topics: PK/PD Modeling & Simulation

Banish hERGphobia: Using Systems Pharmacology to Assess Cardiac Safety

Masoud Jamei

Is the era of “hERGphobia” finally coming to an end? Drug-induced cardiovascular adverse events are one of the leading causes of drug withdrawals from the market and of drug label restrictions. As a result, biopharmaceutical companies are keen to identify new drug candidates with a propensity to cause arrhythmias, or the heart to beat with […]

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Topics: PBPK Modeling & Simulation