What is Toxicokinetics (TK)?
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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What is Allometric Scaling and How Does it Support Drug Development?
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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Metabolites: Formation, Identification, and Impact on Drug Development
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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Understanding the Cost of Pharmacokinetic & Pharmacodynamic Analyses
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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CAR T Cells Part II: Hurdles to Development and Approval
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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CAR T Cells Part I: Design, Production, and Toxicity
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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Monoclonal Antibodies: Past, Present and Future
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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