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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Over the past decade, at least 30 prodrugs have been approved by the US Food and Drug Administration (FDA). It is likely that prodrugs will continue to be important in…
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Nonclinical study data submitted to the FDA must align with the Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM). The version of data standards for nonclinical studies…
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Because of the importance of clinical pharmacology to drug development, it is essential to consider the expertise of your product development team early and to determine whether additional clinical pharmacology…
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Chimeric antigen receptor T-cell (CAR T) therapy is a revolutionary immunotherapy that uses cells from the patient’s immune system to fight certain kinds of cancer. The first two FDA approved…
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The 505(b)(2) New Drug Application (NDA) is a streamlined NDA process in which the applicant relies upon one or more investigations conducted by someone other than the applicant and for…
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In recent weeks, the world has welcomed very positive and much anticipated news on the COVID-19 vaccine front. At least two high-profile vaccines (mRNA vaccines from Pfizer/BioNTech and Moderna) have…
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