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

Bibliographic Details
Corporate Author:	Center for Biologics Evaluation and Research (U.S.)
Format:	Government Document eBook
Language:	English
Published:	Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008]
Subjects:	Immunoglobulins > Pharmacokinetics. Immunoglobulins > Marketing.
Online Access:	https://purl.fdlp.gov/GPO/LPS111654

Description
Item Description:	Title from PDF title page (viewed on Apr. 21, 2009). "June 2008." Electronic resource.
Physical Description:	i, 15 pages : digital, PDF file.
Format:	Mode of access: Internet at the FHA CDER. Web site. Address as of 4/21/09: http://www.fda.gov/cber/gdlns/igivimmuno.pdf ; current access is available via PURL.
Bibliography:	Includes bibliographical references (pages 14-15).