Bioanalysis Zone

Are meaningful predictions of toxicological outcomes in clinical trials based on in vitro diagnostics of preclinical drug candidates possible?


“Early prediction of drug toxicities that would have resulted in lower attrition rates in clinical trials has been unsuccessful, and clinical toxicity remains the main reason why drugs are failing.”

In recent years numerous articles have been written about the abysmal productivity of the pharmaceutical industry in producing novel drugs and the enormous costs put upon the sponsors of clinical trials. The overall expenditure for innovative drug R&D is directly associated with the excessive drug candidate erosion in preclinical and clinical trials [1]. Even slight improvements in timeline and attrition rates within the developmental processes would have given many patients a better quality of life and longer life spans, and most certainly would have created many more jobs in the industry [2].

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