Abstract
The regulation of oral peptide drugs is fundamentally no different from any other medicinal products. Sponsors must demonstrate an acceptable risk-based safety and efficacy profile for an oral peptide drug and must demonstrate suitable control of drug substance and drug product quality by validating production and control processes according to current good manufacturing practices. However, achieving these outcomes for novel therapeutics like oral peptides is often significantly more challenging than for either small molecule orally administered drugs or biologics intended for parenteral administration.
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