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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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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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 nonclinical 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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