There are two broad application categories for drugs and biologics regulated by the United States Food and Drug Administration (FDA): requests for authorization for clinical investigations requests for marketing approval…
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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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Currently, there is a need for novel cancer therapies. This is due not only to the prevalence and biological complexity of this class of diseases but also to the intractability…
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It’s never too early to start planning for your NDA Begin assembling your NDA early Understand the relevant statutes and regulatory guidelines that apply to your program Use standardized templates…
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Real-world data (RWD) are data that come from sources other than traditional clinical trials and are becoming increasingly important to today’s healthcare decisions. Historically, drug developers have been limited to…
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In order to be approved by the FDA, a drug must be both safe and effective for the indication(s) and conditions of use stated in its prescribing information (i.e., product…
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An in vitro in vivo correlation (IVIVC) is a predictive mathematical model that describes the relationship between an in vitro property of a dosage form (primarily dissolution or drug release)…
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