Pharmaceutical Technology-07-02-2018

Pharmaceutical Technology

High-Shear Mixer with Additional Disperser

July 02, 2018

Product Spotlight

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The PowerMix Model PDM-10 from Ross, Charles & Son offers high-shear mixing for hard-to-mix applications with low flowability.

Particle Sizer for Dry and Wet Measurement

July 02, 2018

Product Spotlight

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The Analysette 28 ImageSizer from Fritsch provides analysis of particle shape and size for dry measurement of powders and bulk solids and wet measurement of suspensions and emulsions.

Be Quick, But Don’t Hurry

July 02, 2018

From the Editor

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After 30 years of biologic-drug advances, the industry and patients still have a lot to learn.

Biosimilars Raise Manufacturing and Regulatory Challenges

July 02, 2018

Regulatory Watch

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FDA seeks more efficient testing to spur development of less costly biotech therapies.

Collaboration on GMP Inspections Has Been Successful but Challenges Exist

July 02, 2018

Regulatory Watch

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EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.

Seeking Regulatory Advice

July 02, 2018

Ask the Expert

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Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

Responding to FDA CAPA Requests

July 02, 2018

Cover Story

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Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.

Maintaining GMPs Requires Continued Vigilance

July 02, 2018

Cover Story

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Maintaining good quality control practices throughout the entire manufacturing process requires robust development, a drive toward product and process understanding, and pre-established, comprehensive written procedures that are consistently reviewed and updated.

Oral Delivery of Macromolecular Drugs

July 02, 2018

Peer-Reviewed Research

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Macromolecular drugs are typically injected, but oral dosage forms are being developed to improve the treatment of gastrointestinal conditions such as inflammatory bowel disease.

Pharmaceutical Technology, July 2018 Issue (PDF)

July 02, 2018

Issue PDF

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Click the title above to open the Pharmaceutical Technology July 2018 issue in an interactive PDF format.