This guidance is the second revision of Q1A Stability Testing of New Drug Substances and Products, which was first pu...

The following guideline is an extension of the Note for Guidance on Stability testing of New Drug Substances and Prod...

This guidance recommends that abbreviated new drug applications (ANDAs) submitted under section 505(j) of the Federal...

Full list of ITGs. The guides that are applicable to drugs and medical devices were added to mymedpharm.info are list...

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Термины из документов, включенных в библиотеку, на русском и английском языках с определениями и ссылками на документ...