Determining the delivery, exposure and disposition of a therapeutic agent in nonclinical species is a critical consideration in any early drug development program to enable success in the clinic. Understanding…
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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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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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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” drug). However, it is…
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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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Content updated on November 11, 2020 Cellular therapies promise to revolutionize personalized medicine. These therapies offer new approaches for treating, and possibly curing, previously intractable diseases. One of the most…
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