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Record Nr. |
UNINA9910829813403321 |
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Autore |
Weinberg Sandy <1950-> |
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Titolo |
Guidebook for drug regulatory submissions [[electronic resource] /] / Sandy Weinberg |
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Pubbl/distr/stampa |
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Hoboken, N.J., : John Wiley, c2009 |
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ISBN |
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1-282-02803-0 |
9786612028038 |
0-470-45618-3 |
0-470-45617-5 |
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Descrizione fisica |
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1 online resource (392 p.) |
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Disciplina |
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Soggetti |
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Drugs - Law and legislation - United States |
Drug approval - United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Description based upon print version of record. |
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Nota di bibliografia |
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Includes bibliographical references and index. |
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Nota di contenuto |
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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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Sommario/riassunto |
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Destined to become every regulatory director's essential desktop companion rofessionals working to submit major documents to the Food and Drug Administration (FDA) are guaranteed to encounter numerous unexpected and daunting hurdles. Guidebook for Drug Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during drug development. Demystifying this complex, high-stakes process, author and nationally recognized drug regulation expert Sandy Weinberg presents professionals with authoritative tips, tool |
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