Preclinical Studies in the Drug Development Process: Prospects and Challenges

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Authors : Abonyi Livinus Chibuzo, Abonyi Livinus Chibuzo


The process of drug discovery is lengthy and tortuous, spanning several years. These years are characterized by different stages of differing development processes. A major stage in this development process is the preclinical stage, which is characterized by testing the drug candidate in animal models as a predictor of its efficacy and tolerability in humans. Preclinical drug trial is froth with challenges, which range from choice of the appropriate animal species to generation of the relevant data for filling application for IND.

A successful pre-clinical trial is still not a guarantee of the drug product scaling through the clinical stage. These have been attributed to heterogeneity differences in the animal and human species. Effort in genomic research to circumvent this challenge is presently on-going.


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