Drug development is a complex process where clinical pharmacology data must be generated to support regulatory approval and marketing authorization. Each drug program has unique challenges and special circumstances, but…
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First-in-Human (FIH) studies are designed and conducted based on nonclinical data submitted to and reviewed by regulatory authorities. For the very first trial in humans, nonclinical toxicology, pharmacology, pharmacokinetics, in…
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A 505(b)(2) application is a hybrid of a full new drug application and an abbreviated new drug application. The terms 505(b)(2), 505(b)(1), and 505(j) all refer to sections of the…
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Modeling and simulation utilize existing and prospectively collected data from Phase 1 and 2 clinical studies, nonclinical studies, and from the literature to provide important insights on a drug’s effectiveness…
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Across the spectrum of therapeutic indications, typically, the majority of new investigational drugs are evaluated in randomized dose-ranging clinical trials. These types of clinical trials enable a reasonable understanding of…
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It’s common knowledge that every approved drug on a pharmacy shelf must undergo extensive testing to demonstrate safety and efficacy. However, there is much more that goes into the approval…
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Good Laboratory Practices (GLP) provide regulations and the standard by which drug safety studies are conducted in nonclinical animal studies. In addition to ensuring the ethical treatment and welfare of…
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