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Based on the data generated, the ANDA applicant should be better positioned to manage any bioequivalency issues arising during the drug product development phase and be able to leverage the knowledge gained to give support to its ANDA filing.

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The video we watched was not particularly barbaric; anesthetic was used, etc.

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The shape of the pill is the intellectual property of the manufacturer and reproducing it will qualify as a breach of copyright as well.

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