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Pharmaceutical Technology-02-02-2021

Pharmaceutical Technology

Drug Developers Put Pedal to the Metal

February 03, 2021

Cover Story

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New approaches to clinical trials, spurred by the COVID-19 pandemic, have dramatically shortened development timeframes. Can these gains be sustained once conditions return to normal?

The Value of Pharmacopeial Reference Standards

February 03, 2021

Peer-Reviewed Research

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This article provides an overview of the key risks that can be associated with the use of secondary reference standards (RS) and illustrates scientific challenges associated with transitioning from pharmacopeial RS to secondary RS.

FDA Inspection Shutdown Increasingly Delays Approvals

February 02, 2021

Regulatory Watch

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FDA puts applications on hold as the agency limits alternative oversight methods.

Getting Tough on Supplies

February 02, 2021

Regulatory Watch

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The EC intends to get tougher on issues such as reliability of drug supplies, particularly essential medicines.

In Short Supply

February 02, 2021

From The Editor

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COVID-19 vaccine supplies are breaking news headlines, in both ‘good’ and ‘not so good’ ways.

How Pharmaceutical Innovation is Saving the World

February 02, 2021

From The Editor

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Viewpoint: Mike Hennessy, Sr., founder and chairman of MJH Life Sciences, commends the leadership of the pharmaceutical industry in combatting the COVID-19 pandemic.

Frequently Asked Questions on Regulatory Inspections

February 02, 2021

Ask the Expert

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Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding regulatory inspections, although many of the concepts can be applied to internal and supplier audits as well.

Compact Granulation Line

February 02, 2021

Product Spotlight

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Romaco Innojet’s IGL 100 granulation line is intended for production-scale processing applications and combines high-shear mixing and granulation, fluid bed drying, fluid bed granulation, fluid bed pellet coating, and fluid bed hot melt coating into one unit.