Accelerating drug development // Drug Repurposing

Accelerating drug development

Figure 1.

Current time‐scale of drug approval process. New drugs are developed through several phases: synthesis and extraction of new compounds, biological screening and pharmacological testing, pharmaceutical dosage formulation and stability testing, toxicology and safety testing, phase I, II and III clinical evaluation process, development for manufacturing and quality control, bioavailability studies and post‐approval research. Before testing in humans can start, a significant body of pre‐clinical data must be compiled, and appropriate toxic doses should be found for further in vivo testing to ensure human safety. Toxicology, pharmacology, metabolism and pharmaceutical sciences represent the core of pre‐clinical development.

The current process of identifying a new drug and bringing it to market involves several lengthy steps. It starts with the synthesis of small molecules to target specific proteins or enzymatic activities in living cells. The next step is to identify those compounds that have the best chance of survival in clinical trials. These drug candidates are then subjected to a battery of in vitro tests to investigate potential class‐ and compound‐specific toxicity; it is in these early stages that most candidates fail. Compounds that make it through this stage are then subjected to acute and short‐term in vivo toxicology studies. All information gathered in these pre‐clinical stages is then used as a guide for subsequent clinical trials in human volunteers and patients. It is on these pre‐clinical and clinical tests that new technologies could have the largest impact.

Figure 2.

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