Guidance for industry : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process.
| Other author/creator | Center for Drug Evaluation and Research (U.S.) |
| Other author/creator | Center for Biologics Evaluation and Research (U.S.) |
| Format | Electronic and Book |
| Publication Info | Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2005] |
| Description | 1 online resource (14 p.) |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS113768 |
| Subject(s) |
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| Portion of title | Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process |
| Portion of title | Comparability of biotechnological/biological products subject to changes in their manufacturing process |
| General note | Title from title screen (viewed on June 16, 2009). |
| General note | "ICH". |
| General note | "June 2005". |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Bibliography note | Includes bibliographical references (p. 14). |
| Technical details | Mode of access: Internet at the FDA web site. Address as of 6/15/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm128076.pdf ; current access is available via PURL. |
| GPO item number | 0499-T (online) |
| Govt. docs number | HE 20.4702:B 52/2 |
Available Items
| Library | Location | Call Number | Status | Item Actions | |
| Joyner | Electronic Resources | Access Content Online | ✔ Available |