Monthly Archives: June 2015
Promoting quality standards for drug products: Scientifically speaking, please be systematic and logical!
It appears that talking about the quality of drugs/pharmaceuticals and their products has become a fashionable topic, in particular with respected scientists and regulators. There appears to be clear fearmongering and a blame-game approach that is taking place to discuss the subject and perhaps to gain personal or professional recognition along the way. Such human elements are natural or expected; however, when it comes to science then such emotional distractions should be managed, preferably set aside. This article is an attempt to provide a rationale and scientific point of view to highlight current difficulties in setting standards for developing and manufacturing quality drug-products, in particular tablet and capsule.
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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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