Clinical Pharmacology Strategy

Benefits of Apocalyptic Clinical Pharmacology During Regulatory Review

Graham Scott

When developing a drug, pharmaceutical companies need to answer many questions to successfully undergo regulatory review and bring the drug to market. Apocalyptic clinical pharmacology is a framework that drug developers can use to uncover essential relationships between the drug dose and response or outcome. In other recent blog posts, I have covered what the […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Lessons Learned: Case Studies of Apocalyptic Clinical Pharmacology

Graham Scott

Apocalyptic clinical pharmacology helps drug developers save resources and time through providing a framework for understanding the interaction of the drug under development with the biological system. This framework also helps answer questions from regulatory authorities who are evaluating the safety and efficacy of the drug. Making informed decisions throughout the drug development process requires […]

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Topics: Clinical Pharmacology Strategy, PBPK Modeling & Simulation

Introduction to Apocalyptic Clinical Pharmacology in Drug Development

Graham Scott

In this blog, I will introduce “apocalyptic clinical pharmacology” and provide a framework for using this approach in drug development, which can save resources and time. Apocalyptic clinical pharmacology in drug development provides value offering a framework for thinking about the relationship between the drug dose and the biological system. What is apocalyptic clinical pharmacology? […]

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Topics: Clinical Pharmacology Strategy, PK/PD Modeling & Simulation

Certara’s Best of the Blog 2017

A selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.

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Apocalyptic Clinical Pharmacology: A Comprehensive Approach to Drug Development

Watch this webinar with Dr. Graham Scott, Senior Director of Clinical Pharmacology at Certara Strategic Consulting, to learn why you should invest in “apocalyptic clinical pharmacology.” Dr. Scott presented case studies that illustrate how sponsors can benefit from a clinical pharmacology strategy that uses model-informed approaches to inform and “fill in the gaps” of clinical trials.

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First-in-human Trials and Going Too FAAH from the Sentry

Graham Scott

Many people in the UK and elsewhere are currently remembering where they were and what they were doing on the day that Diana Princess of Wales died: August 31st marks 20 years since that fateful day. For Clinical Pharmacologists, we may well remember where we were when we heard the news that six volunteers were […]

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Topics: Clinical Pharmacology Strategy