Global Impacts of COVID-19 on Drug Development
If you missed our live panel discussion on how the drug development industry is being impacted by the COVID-19 pandemic, we have assembled this post to highlight some of the…
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What is Allometric Scaling and How Does it Support Drug Development?
There are many aspects of drug development that must be understood before a drug can be tested in humans. Nonclinical studies are conducted to understand the safety (i.e., toxicity and…
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What is IVIVC?
Content updated on August 11, 2021 An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a dosage…
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FDA Recently Revised the 1999 Population Pharmacokinetic Guidance
The US Food and Drug Administration (FDA) released a new draft guidance on Population Pharmacokinetics (popPK) in July of 2019. The original popPK guidance was published in 1999, making it…
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What is a Human Mass Balance Study?
Content updated on July 28, 2021 The goal of a human mass balance clinical study is to understand how drugs are absorbed, metabolized, and excreted (AME) after dosing. This information…
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Pharmacokinetics in Patients with Hepatic Impairment
The liver is responsible for the metabolism and clearance of many different drugs and their metabolites. Because of the liver’s importance in removing drugs from the body, diseases or injuries…
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How to Successfully Prepare for Your Pediatric Study Plan
Content last updated on December 2, 2020 by Lauren R. L. Lohmer, Ph.D. Laws were implemented surrounding the safety and efficacy of drugs and biologics starting in the early 1900s,…
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