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.
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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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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Oral Solid Dosage Formulations (OSDF) bring progress with medicines that improve health and quality of life. The process to progress however, goes unseen by customers when they do not recognize your ...
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What can companies do to improve their Track and Trace capabilities?
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What is the importance of labeling in “track and trace?”
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Is your dust collection system effectively controlling hazardous solid dose production dust? If you’re not sure, there’s a way to test the system to learn if it is potentially exposing employees to ...
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One stone tossed into water creates many ripples. Sometimes those
ripples reach farther and impact more things than the thrower initially
intended or realized. Such is the case when the US Congress ...
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Although coating has been a standard part of pharmaceutical tablet and pellet production for decades, some problem areas still persist — quality, productivity, and flexibility. Aspects of these ...
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