Pharmaceutical Technology-10-02-2017

Pharmaceutical Technology

Pharma’s Role in Puerto Rico’s Future

October 02, 2017

From the Editor

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Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.

Starting Early is Key to De-Risking Drug Development

October 02, 2017

Cover Story

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The pharmaceutical industry is under tremendous pressure to make drug development faster and cheaper. Applying the right formulation strategy using structured and rigorous science can help avoid costly failures and re-starts, but it’s important to start from an early stage.

Pharmaceutical Environmental Pollution and Antimicrobial Resistance

October 02, 2017

Regulatory Watch

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The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.

FDA User Fees Promote Manufacturing Readiness

October 02, 2017

Regulatory Watch

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Industry and FDA face new fee structures and new challenges in implementing fee initiatives.

Making Decisions Based on Risk

October 02, 2017

Ask the Expert

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Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Analytical Data System Update

October 02, 2017

Product Spotlight

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An updated version of Shimadzu’s LabSolutions analytical data system incorporates additional functions to comply with data integrity regulations, and to support development and quality inspection procedures.

Is Your Tablet Hard to Swallow? Guidance Addresses Drug Tablet Design

October 02, 2017

Features

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EMA and FDA guidance encourages design of drug products to improve patient compliance.

Singlet Determination Revisited

October 02, 2017

Statistical Solutions

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Is there a difference between a specification and a standard?

Six Sigma and the Path to Quality

October 02, 2017

Features

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Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry.

Pharmaceutical Technology, October 2017 Issue (PDF)

October 02, 2017

Issue PDF

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Click the title above to open the Pharmaceutical Technology October 2017 issue in an interactive PDF format.