Pharmaceutical Technology-01-02-2013

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Pharmaceutical Technology

January 02, 2013

The Future of Pharma Manufacturing

Inside USP
Pharmaceutical Technology

January 02, 2013

USP's focus in 2013 involves standards relating to organic impurities, measurement of residual DNA and host-cell proteins in biotechnology products, and elemental impurities.

Pharmaceutical Technology

FDA talks about the changing scope of regulatory science and its effect on drug reviews, site inspections, and overall approaches.

Pharmaceutical Technology

Is process-centered organization in biopharmaceutical manufacturing a stepping stone or a stumbling block?

Pharmaceutical Technology
Product Spotlight

January 02, 2013

New product reviews for December 2012.

Pharmaceutical Technology
From The Editor

January 02, 2013

From time to time, it's important to take stock of the industry from both a retrospective and prospective point of view.

Pharmaceutical Technology
News

January 02, 2013

A round up of news from across the web, including trends from social social media platforms.

Pharmaceutical Technology
API Synthesis and Manufacturing

January 02, 2013

Process chemists employ a variety of approaches to improve yield, purity, and stereoselectivity.

Pharmaceutical Technology
Global Feature

January 01, 2013

The health ministry of Brazil recently signed an agreement to obtain its production technology to locally develop the antiretroviral drug atazavanir sulfate.

Pharmaceutical Technology

The authors discuss the valuable information that can be obtained from indexing and its applications in routine screening and analysis of solid forms.

Pharmaceutical Technology
Outsourcing Outlook

January 01, 2013

Will international biomanufacturing outsourcing become mainstream in this decade?

Pharmaceutical Technology
Regulation & Compliance

January 01, 2013

The EU fine-tunes legislation for the Falsified Medicines Directive, which is due to take effect this month as part of efforts to better protect patients from counterfeits.

Pharmaceutical Technology
Ask the Expert

January 01, 2013

Siegfried Schmitt, a principal consultant with PAREXEL, discusses the EMA's guideline on process validation and how it compares with FDA's process validaton guidance.

Pharmaceutical Technology
CMC Troubleshooting

January 01, 2013

Revalidation of cleanroom disinfection may be unnecessary, according to John S. Kent.

Pharmaceutical Technology

Dr. Charles Kettler, director of Natoli Scientific, looks at the challenges that tablet scoring poses to tablet manufacturers.

Pharmaceutical Technology
Regulation & Compliance

January 01, 2013

Shortages and compounding disaster spur efforts to overhaul manufacturing oversight and stimulate industry improvements.

Pharmaceutical Technology
Special Feature

January 01, 2013

Tablet splitting is a new area of focus for regulators. The FDA tells PTE more about the challenges in this area.