There are many aspects of drug development that must be understood before a drug can be tested in humans. Nonclinical studies are conducted to understand the safety (i.e., toxicity and…
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by Scientific Writing Team Much of the drug development process focuses on characterizing the activity and safety profile of the drug substance (i.e., the active pharmaceutical ingredient [API] or “parent”…
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How much does PK/PD cost? While a very common question, it is not one that is easy to answer. The cost of PK/PD depends on many factors but, in general,…
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In our previous blog post, we discussed the revolutionary immunotherapies known as chimeric antigen receptor T-cells (CAR T). The first CAR T therapies, axicabtagene ciloleucel (Yescarta™) and tisagenlecleucel (Kymriah™), were…
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In 2017, the FDA approved two revolutionary drugs known as chimeric antigen receptor T (CAR T) cells. These drugs, Kymriah® (tisagenlecleucel) and Yescarta® (axicabtagene ciloleucel), which are both indicated for…
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What is a Monoclonal Antibody? Monoclonal antibodies (mAbs) are antigen-recognizing glycoproteins that are made by identical immune cells, all of which are clones of a unique parent cell. Since 2014,…
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For the vast majority of therapies, FDA requires a clear demonstration of safety and effectiveness in humans before marketing approval is granted. However, while an adequate demonstration of safety in…
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