FDA BE Guidance – Injectables

To facilitate generic drug product availability and assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs. After more than a decade in action, this …

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Safety Assessment of Using Nitrogen Gas in Confined Area

Nitrogen gas is a common inert protecting gas during pharmaceutical manufacturing. It is supplied in either compressed gas cylinders or liquid nitrogen dewars. Continuous usage of nitrogen gas in confined area with limit ventilation or air exchange can pose a serious safety hazard to operators. This article illustrates a practical example of engineering assessment of …

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in vitro Skin Tissue Model in Topical Product Development

Introduction Topical diseases are becoming increasingly attractive to the pharmaceutical industry as an expanding and profitable sector. Once considered a niche therapeutic segment, today skin diseases collectively outnumber conditions such as obesity, hypertension and cancer. The global market for skin therapy reached $17.1 billion in 2015 and with a five-year compound annual growth rate (CAGR) …

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Resources for Topical Generic Product Development

With many blockbuster brand drugs at or near the edge of the so called “patent cliff”, and with significant technical hurdles in biosimilar development, some generic companies are shifting their attention to additional dosage forms or niche products to create product portfolio diversity. One of the market segments that offers multiple sub-billion-dollar product opportunities is …

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No Yield to Yield Stress

Semi-solid and liquid drug products display complex rheological behaviors, which have significant impact on patient compliance, product manufacturability and stability. Aside from Ketchup or toothpaste, there are ample examples of semi-solid and liquid dosage forms where the rheology plays a delicate role in product characteristics. For instance, a medicated shampoo should be easily poured out …

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