Delves into all aspects of R&D and manufacturing of all oral solid dose (OSD) forms. Tracks industry trends. Relays latest applied research relevant to OSDs. Provides “how to” information for the latest techniques in formulation/excipients, tablet manufacturing, capsule filling and other aspects of the process—including logistics like supply-chain management.
When my daughter signed up for Scouts (formerly Boy Scouts of America), I was reminded of the motto I memorized when I was a member: Be Prepared.
That phrase is especially relevant to companies ...
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Developing high-potency, high-performance drugs is hazardous, and the stakes are high for investors, the pipeline, and patients. This class of drugs—known as HPAPIs for short—represents a substantial ...
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An FDA inspection can be one of the most stressful parts of doing business. And while drug pre-approval and pre-license inspections—and most foreign facility inspections are generally pre-announced—...
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How can a company best prepare for an FDA inspection?
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The Generic Drug User Fees Amendment III (GDUFA III) program administered by the FDA Office of Generic Drugs has many promises in the making to approve quality generic drugs for the American public. ...
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A list of resources to help prepare for an FDA inspection.
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OSD Industry Experts Reflect on Opportunities and Challenges in 2023 and Beyond
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Tooling plays a critical role in manufacturing quality tablets, requiring care in handling, cleaning, inspecting, measuring, and storing. Documenting these maintenance steps improves efficiency, ...
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A drug’s efficacy is linked inextricably to its solubility. Without it, drugs are less effective or not effective at all, because they don’t achieve therapeutic concentration in the patient’s body. ...
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Consumers have shown heightened concern about contaminants being discovered in products such as foods and pharmaceuticals. Despite the publicity surrounding such incidents, and despite the rigorous ...
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Pill fatigue is a real phenomenon that is shaping consumer choice regarding the nutraceuticals millions of people voluntarily prescribe themselves every day. Pill fatigue has many sources, but it ...
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Patient safety is at the heart of all quality systems in the pharmaceutical industry. Ensuring patient safety, in turn, requires adherence to quality standards that can vary from country to country. ...
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“It’s tough to make predictions, especially about the future,” said Yogi Berra, the former baseball player and coach who became more famous for his malapropisms than for his sports career. Berra’s ...
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Saying one is “for the Earth” is akin to saying one likes puppies or small children—a basic platitude that, on its face, seems difficult to argue. But seeking sustainability is more complex, even in ...
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Pharma’s environmental footprint almost equals that of the automotive sector—but the pharmaceutical industry is seeking to reduce it. Ever since the Kyoto protocol was ratified in 1997 to address the ...
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