By Richard A. Guarino,Richard Guarino

The completely revised 5th version of latest Drug Approval strategy provides readers with the most recent international alterations that impact pharmaceutical product approval and effect how new items are researched and marketed.

Updated chapters include:

  • advances in foreign regulatory requisites, together with ICH guidance and harmonization

  • a step by step layout for content material, meeting, and strategic strategy in submitting US and worldwide INDs, NDAs, BLAs, ANDAs, and SNDAs

  • the most modern regulatory specifications for expediting new drug approvals

  • strategies for potent verbal exchange and integration of pharmaceutical team of workers in all facets of recent drug development

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New Drug Approval Process, Fifth Edition: 190 (Drugs and the Pharmaceutical Sciences) by Richard A. Guarino,Richard Guarino

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