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  Indian J Med Microbiol
 

Figure 3 Method for process and clinical development. Clinical development is initiated by preliminary point of care (POC) toxicity trial along with investigational new drug toxicity trial, followed by Phases 1, 2, and 3 of clinical trials. Finally, biologics license application review is performed. Process development takes place simultaneously with preliminary studies of POC toxicity being performed and pre-IND process development of Phase 1 trial. This is then followed by pre-phase 2 and pre-phase 3 of the process development. The preapproval validation is carried out along with the biologics license application. IND, Investigational New Drug

Figure 3 Method for process and clinical development. Clinical development is initiated by preliminary point of care (POC) toxicity trial along with investigational new drug toxicity trial, followed by Phases 1, 2, and 3 of clinical trials. Finally, biologics license application review is performed. Process development takes place simultaneously with preliminary studies of POC toxicity being performed and pre-IND process development of Phase 1 trial. This is then followed by pre-phase 2 and pre-phase 3 of the process development. The preapproval validation is carried out along with the biologics license application. IND, Investigational New Drug