A compound is deemed to be potent in pharmaceutical terms if it has an eight-hour, time- weighted average occupational exposure limit (OEL) of 10 μg/m3 or less. There is, however, no formally agreed definition of the OEL level that constitutes a "highly potent" compound. What are the main uses of HPAPIs in today's pharma sector?Interest in highly potent drugs is largely driven by oncology research and more targeted therapies across a number of indications. Currently, over 1,000 highly potent small molecules are in development, with approximately 30% targeting oncology, 20% for antidiabetics, 20% for autoimmune diseases and the remainder for other indications. Cardiovascular, CNS and immunology are also strongly represented in the drive for HPAPIs. Can you talk a bit about the approval process for these ingredients, and what are some trends in the regulatory landscape right now? The regulatory environment for active Pharmaceuticals is changing with the increase in regulators' granting accelerated approval pathways - especially in oncology. In early development, there is often insufficient toxicology data to determine the OEL at which the compound should be contained, so companies should follow a more conservative approach to containment. Health and Safety Executive (HSE) teams worldwide are defining OEL in development phases based on computer simulations, similarities to known compounds, or simply by defaulting to highly potent compounds in the first place and only relaxing constraints when more toxicology data is available.
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