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Title Guidance for industry [electronic resource] : safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency.

Imprint Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:IM 9    ---  Available
Description i, 15 p. : digital, PDF file
System Details Mode of access via the FHA CDER web site.
Note Title from PDF title page (viewed on Apr. 21, 2009).
"June 2008."
Bibliography Includes bibliographical references (p. 14-15).
Subject Immunoglobulins -- Pharmacokinetics.
Immunoglobulins -- Marketing.
Added Author Center for Biologics Evaluation and Research (U.S.)
Added Title Safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:IM 9

 
    
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