Pharmaceutical Technology-02-02-2005

Pharmaceutical Technology

Correcting the Course

February 02, 2005

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Steer small.

Using Extrusion-Spheronization to Develop Controlled-Release Formulations of Azithromycin

February 02, 2005

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29

2

Extrusion-spheronization and pellet compression are effective means of developing first-order kinetic, controlled-release drug delivery systems of azithromycin (AZI). The authors prepared, evaluated, and optimized AZI formulations and assessed the stability of the selected formulation under accelerated storage conditions.

Toward a Generic Approach for Stress Testing of Drug Substances and Drug Products

February 02, 2005

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29

2

The Impurity Profiling Group reviews stress testing according to regulatory guidance documents. The authors emphasize what should be considered for late clinical phases and for registration application dossiers.

February 2005

February 02, 2005

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29

2

Pharmaceutical Science & Technology News

Good Work and True: USP Prepares for Convention 2005

February 02, 2005

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29

2

The USP prepares for its quinquennial conference in March.

Contract Manufacturers Getting Squeezed

February 02, 2005

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29

2

Too many players and threats to the main customer base challenge European dose manufacturers.

In the Spotlight-February 2005

February 02, 2005

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29

2

Pharmaceutical Science & Technology Innovations

Emerging Analytical Technology: Moving from the Lab to the Line

February 02, 2005

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29

2

Analytical instrument suppliers are developing manufacturing-tailored tools that are small, precise, and easy to use.

Drug Safety Fears May Limit Reimporting and Shape R&D

February 02, 2005

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29

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Concerns about risky medicines may reduce pressure to expand drug imports while boosting demand for more comparative analyses of therapies.

In Defense of USP Singlet Testing

February 02, 2005

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The United States Pharmacopeia should not change its philosophical position on singlet testing.