Articles by Angie Drakulich - Pharmaceutical Technology

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Articles by Angie Drakulich

FDA Issues Guidance Agenda for 2012

Mar 8, 2012

FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.

Genotoxic Impurities: A Q&A with Amgen's Bo Shen

Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges.
Mar 2, 2012

Genotoxic impurities and how to identify them and control for them have been a concern for several years in the pharmaceutical manufacturing industry. Pharmaceutical Technology spoke with Bo Shen, PhD, principal scientist at Amgen and chair of the AAPS Pharmaceutical Trace Impurities Focus Group, to gain insight on key challenges.

Platform Technologies

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.
Mar 2, 2012

The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.

FDA Guides the Way to Biosimilars in the US

Has the long-awaited guidance answered all of the industry's questions?
Mar 2, 2012

Has the long-awaited guidance answered all of the industry's questions?

Physical-Chemical Identifiers: A Q&A with FDA on the Final Guidance

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.
Mar 1, 2012

FDA answers key questions about the October 2011 guidance on using physical–chemical identifiers in solid oral dosage products to help prevent and avoid counterfeiting.

An Enhanced Approach to Drug-Substance Development and Manufacture

FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.
Feb 2, 2012

FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.

Sustainable Investment

Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.
Feb 2, 2012

Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.

Global Healthcare on the Ground: Brazil's Development Bank Leader Discusses the Country's Pharma Future

As part of the BRIC bloc with Russia, India, and China, Brazil is one of the world's leading emerging economies and is also considered by IMS Health to be one of seven pharmerging nations, which also include Mexico, Turkey, and South Korea.
Jan 2, 2012

As part of the BRIC bloc with Russia, India, and China, Brazil is one of the world's leading emerging economies and is also considered by IMS Health to be one of seven pharmerging nations, which also include Mexico, Turkey, and South Korea.

Here's to a Year of Compromise

The benefits of harmonization may be on industry's wish list, but buying into change is another story.
Jan 2, 2012

The benefits of harmonization may be on industry's wish list, but buying into change is another story.

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