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Specification Setting During Chemical API Development

Over the last twenty years or so, the paradigm behind setting specifications has undergone something of a transformation. Much can be attributed to the adoption of risk-based methodologies, such as Quality by Design (QbD), advancements in technology, and harmonization of world regulatory expectations. The Art of Medicinal Science Specification setting […]

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What You Need to Know About Contract Pharma Project Onboarding and Kickoff

Successful pharmaceutical project onboarding – whether at a CRO, CMO or CDMO – hinges on three key factors: Flexibility Communication Relationships. All of these factors depend heavily on the project team. Select the Right Project Manager One of the most important elements of successful drug substance project onboarding is project […]

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Exploring Analytical Method Development for Drug Substances

The objective of drug development is to successfully get a lead compound into clinical trials and ultimately to the patient population – as quickly as possible. Yet, just as important as speed is safety. In fact, if the applied analytical methods are not measuring the right parameters, speed-to-market becomes a […]

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Supercritical Fluid Chromatography: A Greener, Cheaper, and Faster Alternative in Normal Phase Chromatography

Earth Day is coming up soon, which means we’ll see a focus on how companies are trying to do their part to be environmentally friendly. Businesses worldwide are implementing green initiatives, and those initiatives may look quite different depending on the industry. In some sectors, going green means installing solar […]

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Managing Impurities During Clinical Trials

Impurity control is a critical aspect of any pharmaceutical development process, but regulatory guidance tends to be vague where limited use during clinical trials is concerned. According to AstraZeneca’s Andrew Teasdale: “Permissible limits for impurities during clinical development has always been a grey area. Existing guidelines, specifically ICH Q3A, only […]

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