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Newsletter Sponsor
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Recro Gainesville | Reformulating an Approved Drug?
How do you gain approval for a modified formulation of a previously approved drug — without repeating clinical testing?
It takes knowledge of the options, a successful strategy, experience in formulation development, and skill in presenting a confident, science-based case to the regulatory agency.
Get the story of how we saved our client significant time and expense.
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Featured Articles |
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An Interview with... Alcami
If current trends hold, it is expected that new parenteral products will be increasingly complex, requiring nonstandard manufacturing technologies subjected to higher standards of regulatory scrutiny ...
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Featured Partners |
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[Webinar] Pharmaceutical Development of Oligonucleotides
Oligonucleotides are an emerging class of DNA and RNA therapeutics that address a number of unmet medical needs. As with many biopharmaceuticals, the complex structure of oligonucleotides makes their large-scale synthesis both challenging and imperfect. A number of impurities are generated during manufacturing, many of which are hard to identify using available analytical methods. Furthermore, the...
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Featured Whitepaper |
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Vcaps Plus Capsules
Hypromellose (HPMC) capsules were originally formulated with a secondary gelling agent. This agent can delay dissolution in some circumstances and ...
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Events
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CPhI China
Shanghai, China – 06/18/2019
CPhI & P-MEC China 2019 is your gateway to successfully growing your business at the 2nd largest pharma market in the world. Whether you are looking ...
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