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The FDA published a number of draft and final guidance documents in 2022. In this e-book, we summarize the most important guidance documents related to pharmaceutical production so that you can start 2023 with a strong understanding of regulatory perspective.
By Mark Durivage, Quality Systems Compliance LLC ICH has revised , and it provides principles and tools for quality risk management that can be applied throughout the product life cycle of drug substances, drug products, and biological and biotech products. The FDA, a founding member of the ICH, plays a major role in the development of ICH guidelines, which FDA then adopts and issues as guidance to industry. Submit comments by July 15, 2022.
By Ron Connolly, Senior Business Advisor, Adare Pharma Solutions Are you searching for ways to accelerate first-in-human and dose escalation studies? Do you believe you are wasting R&D resources at earlier stages of development by making customized dosage forms for a specific clinical study that may never be used for a commercial product? Are you trying to formulate combination products with known chemical interactions?
A major challenge when taking drug candidates from clinical studies to market is finding robust product formulations that can be used from early stage studies through product commercialization. Early stage clinical studies frequently use Active Pharmaceutical Ingredient powders or oral suspensions that may have limitations in stability or bioavailability, necessitating potentially time-consuming, costly reformulations as doses are established during later development trials.
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