Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
Certara scientists performed helped a small biotech company create a clinical pharmacology package for their NDA submission for a novel oncology drug.
Read MoreMedicines Development for Global Health (MDGH), a not-for-profit biopharmaceutical company, needed integrated, model-informed drug development expertise to support developing a treatment for river blindness. Learn how Certara’s clinical pharmacology, pharmacometrics, and regulatory strategy expertise yielded a significant financial, scientific, and regulatory ROI to MDGH.
Read MoreMaximize your understanding of your anti-cancer drug’s safety and efficacy profile to achieve regulatory and commercial success with Certara’s strategic and technology-enabled services across the entire drug development continuum – from pre-clinical first-in-human studies to regulatory submissions, health economics/outcomes research and market access value communication.
Read MoreOrphan drugs affect 350,000 people worldwide, including 10% of the US population and 1 in 25 Europeans. Model-informed drug development (MIDD) approaches, such as PBPK and PopPK have been embraced by sponsors and regulators, and play a key role in modernizing and accelerating orphan drug development.
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I created the Learn PK/PD site in May 2010 in response to a communication issue that I was facing in my daily work in the world of clinical pharmacology and pharmacokinetics. In my first post, I stated the reason for creating my blog and the website: My blog is dedicated to providing clear, concise, accurate, and […]
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Mass balance studies are also called “C-14 studies” or “Absorption, Metabolism, and Excretion (AME) studies”. It is important to understand what you are trying to learn from the experiment. The primary objectives of a mass balance study are generally: To determine the mass balance of drug-related material following dose administration To determine the ratio of […]
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After a much longer delay that I expected, I am back to blogging on a regular basis. Today I want to discuss a common topic among clinical pharmacologists. How do you properly design a drug-drug interaction study? Defining drug-drug interactions While these studies may appear complicated, they can be simplified very quickly to make the […]
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Drug-drug interactions are a critical research area in pharmaceutical drug development. One of the most tragic examples of drug-drug interactions was the antihistamine terfenadine. Terfenadine (also known as Seldane) was a common antihistamine intended to block the effects of an allergic rhinitis. Upon administration terfenadine is metabolized to fexofenadine by the cytochrome P450 3A4 isoform. […]
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The primary purpose of a clinical trial is to address a scientific hypothesis. To address a hypothesis, different statistical methods are used depending on the type of question to be answered. Most often the hypothesis is related to the effect of one treatment as compared to another. For example, one trial could compare the effectiveness […]
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