Guidance for industry : safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency.
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Format | Electronic |
| Publication Info | Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, [2008] |
| Description | i, 15 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS111654 |
| Subjects |
| Portion of title | Safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency |
| General note | Title from PDF title page (viewed on Apr. 21, 2009). |
| General note | "June 2008." |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references (p. 14-15). |
| Technical details | 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. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:IM 9 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |