Traditionally, the treatment of human disease has been dominated by small molecule drugs. Small molecules are used to treat a variety of diseases and conditions and can be quite diverse…
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Toxicokinetics (TK) is defined as the generation of pharmacokinetic (PK) data, either as an integral component in the conduct of non-clinical toxicity studies or in specifically designed supportive studies to…
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A fundamental question for any drug development program is which regulatory pathway to pursue. The answer is important to determine early on, because it dictates the scope of clinical and…
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The Power of Vaccinations Every year, vaccines are administered to millions of people to mitigate the spread of a wide variety of infectious diseases. One of the best known and…
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An active Investigational New Drug (IND) application is required by the U.S. Food and Drug Administration (FDA) before human studies may be conducted. For new drugs and even most follow-on…
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Adaptive clinical trial designs have been used extensively in medical device development, and lessons learned are now being applied to drug development. Adaptive design can reduce the number of patients…
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Need a refresher on what steady-state concentration is, how long it takes to reach steady state, and why this value is key in drug development? Here, we answer the most…
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