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Guidebook for drug regulatory submissions / Sandy Weinberg.

By: Material type: TextPublication details: Hoboken, N.J. : Wiley, c2009.Description: x, 379 p. : ill. ; 25 cmISBN:
  • 9780470371381
  • 0470371382
Subject(s): DDC classification:
  • 344.7304233 22 W4231g
Contents:
Ten rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions.
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Holdings
Item type Current library Call number Vol info Copy number Status Barcode
Books Library, Independent University, Bangladesh (IUB) Pharmacy Corner 344.7304233 W4231g (Browse shelf(Opens below)) 2009 01 Not For Loan 029831
Total holds: 0

Includes bibliographical references and index.

Ten rules for drug regulatory submissions -- FDA meeting requests -- Orphan-drug applications -- Investigational new drug applications (INDs) -- New drug applications (NDAs) -- 505(b)2 new drug applications (NDAs) -- Abbreviated new drug applications (ANDAs) -- Annual reports -- International submissions / Carl A. Rockburne -- Future issues in regulatory submissions.

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