Mar 8, 2012
By:
Angie Drakulich
FDA has issued a list of planned draft and final guidance documents for release throughout 2012. There are approximately 50 such guidances planned.
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Has the long-awaited guidance answered all of the industry's questions?
Mar 2, 2012
By:
Angie Drakulich
Has the long-awaited guidance answered all of the industry's questions?
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The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.
Mar 2, 2012
By:
Erik Greb, Angie Drakulich
The standardization of upstream and downstream bioprocessing is growing, but several kinks need to be ironed out.
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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
By:
Angie Drakulich
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.
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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
By:
Angie Drakulich
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.
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FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.
Feb 2, 2012
By:
Angie Drakulich
FDA and industry expert working group representatives discuss the pending ICH Q11 guideline.
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Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.
Feb 2, 2012
By:
Angie Drakulich
Pharma announces plans for the year ahead at annual JPMorgan Global Healthcare conference.
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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
By:
Angie Drakulich
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.
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The benefits of harmonization may be on industry's wish list, but buying into change is another story.
Jan 2, 2012
By:
Angie Drakulich
The benefits of harmonization may be on industry's wish list, but buying into change is another story.
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