Clinical trials preclinical transition

TRANSITIONING FROM PRECLINICAL DEVELOPMENT TO CLINICAL TRIALS... 

A number of regulatory guidance documents touch on various aspects of the transition from preclinical to clinical study of a novel biopharmaceutical. The primary guidance documents describing the conduct and use of preclinical safety evaluation in supporting the initial clinical trials are as follows ... 

An important point to be considered when developing new biomarkers of immunotoxicity is the requirement for many of these to be applicable to animal studies, as well as clinical trials in order to improve the transition from preclinical to clinical immunotoxicity evaluation. In the long run, strategies for animal studies intended to predict unexpected immunotoxicity can be expected... 

Whether or not an optimized lead ever becomes a candidate going into the clinic depends on what happens in the next stage, called preclinical or maybe clinical development candidate selection. Although, the term preclinical can be taken to broadly mean any new drug activity done prior to clinical trials (TID, LID, etc.), it normally refers specifically to this stage, which marks the transition to the D in R D. As such, it s the point where many things change. 

Telomerase inhibitors are just beginning to find their way into human clinical trials. How efficacious and what side effects these inhibitors will have in real patients is difficult to predict. As with most new drugs, the transition from preclinical to clinical studies would be expected to come with its own set of new challenges. In the next sections, we discuss five areas that will necessitate further investigation to ensure the best possible results in patients. 

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