Pharmaceutical Technology-11-02-2019

Pharmaceutical Technology

QbD Takes Shape for Topical Pharmaceuticals

November 08, 2019

Quality/Regulations

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As they seek to increase the number of generics available, regulators are requiring that in-vitro and other test data be used for ANDAs, and promoting the concept of biowaivers that would allow such data to replace costly clinical studies.

Optimizing Compression Coating for Pulsatile Release Tablets

November 08, 2019

Peer-Reviewed Research

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Research examined the effects of varying excipient and polymer weight in coatings designed to optimize the release of diclofenac sodium. The goal was to release it at night to improve the treatment of rheumatoid arthritis.

Innomech Benchtop Systems

November 02, 2019

Product Spotlight

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The new Innomech Benchtop Systems developed for and offered by Aston Particle Technologies (APT) combine two benchtop systems to organize small amounts of blended pharmaceutical powders for use in APT’s formulation development projects.

More Consistent Drug Inspection System on Horizon

November 02, 2019

Regulatory Watch

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FDA readies more efficient oversight processes while advancing collaboration with Europe.

Signatures–What’s in a Name?

November 02, 2019

Ask the Expert

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It is good industry practice to clarify the precise remit for each of the reviewers of a controlled document, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Breaking the Drug Shortage Cycle

November 02, 2019

From The Editor

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FDA report says drug shortages are underappreciated and patients pay a price.

Striking a Landmark Deal

November 02, 2019

From The Editor

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After years of discussions around pricing, UK governmental bodies and Vertex have finally reached an agreement on cystic fibrosis treatments.

Investigating NDMA Impurities at EMA’s Request

November 02, 2019

Regulatory Watch

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Companies are facing a huge undertaking to be able to complete risk evaluations of all medicines containing chemically synthesized APIs by March 2020.

Pharmaceutical Technology North America, November 2019 (PDF)

November 02, 2019

Issue PDF

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Click the title above to open the Pharmaceutical Technology November 2019 issue in an interactive PDF format.