Modeling and simulation are transforming how drugs are developed and how they are regulated. This is the conclusion from a recent FDA Grand Rounds presentation entitled “How Simulation can Transform…
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by Scientific Writing Team Model-Based Drug Development (MBDD), sometimes referred to as Model-Informed Drug Development (MIDD), is a process whereby key program decisions are supported by mathematical models and simulations…
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Today, the cost of developing a new drug is higher than ever, driven in large part by improperly designed, untimely, or unnecessary clinical studies. Companies pour money into a development…
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by Scientific Writing Team “I suppose it is tempting, if the only tool you have is a hammer, to treat everything as if it were a nail.” – Abraham Maslow…
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What are some of the most common and costly mistakes sponsors make when it comes to collection of pharmacokinetic (PK) samples in clinical studies? In this post, we will discuss…
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Renal Impairment Studies for FDA Approval – Common Questions and Answers Is a renal impairment study needed for your drug development program and NDA/BLA? The answer depends on a lot…
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Despite the enormous amount of time, effort, and money invested in testing new drugs, clinical trial failures are a common occurrence. According to a recent report a, the overall likelihood…
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