Establishing safety, efficacy and quality of drugs and drug-products (tablet/capsule) – serious confusion!

These terms (safety, efficacy and quality) are frequently used in literature, apparently without clear description and relevance. The lack of clarity and relevant use of the terminologies appear not only to cause confusion, but also at present seriously hinders the development and assessment of pharmaceutical products, such as tablets and capsules. It is highly unlikely that improvements in manufacturing practices of pharmaceuticals and their assessment, including associated regulatory standards and assessments, are possible without clearly explaining and objectively defining these terms. The purpose of this article is to help in explaining these terms considering the underlying scientific concepts in order to facilitate improved product development and assessment.

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