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Guidance for industry immediate release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation.
Saved in:
Corporate Author: | |
---|---|
Format: | Government Document Electronic eBook |
Language: | English |
Published: |
[Rockville, Md.] :
Center for Drug Evaluation and Research,
[1995]
|
Physical Description: |
1 electronic resource (26, 1 page) |
Subjects: | |
Online Access: | https://purl.fdlp.gov/GPO/LPS121078 Full text |
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245 | 0 | 0 | |a Guidance for industry |h [electronic resource] : |b immediate release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. |
246 | 3 | 0 | |a Immediate release solid oral dosage forms. |
246 | 3 | 0 | |a Scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. |
264 | 1 | |a [Rockville, Md.] : |b Center for Drug Evaluation and Research, |c [1995] | |
300 | |a 1 electronic resource (26, 1 page) | ||
336 | |a text |b txt |2 rdacontent. | ||
337 | |a computer |b c |2 rdamedia. | ||
338 | |a online resource |b cr |2 rdacarrier. | ||
500 | |a "CMC 5"--prelim. p. | ||
500 | |a "November 1995." | ||
500 | |a GPO Cataloging Record Distribution Program (CRDP). | ||
504 | |a Includes bibliographical references (pages 25-26). | ||
650 | 0 | |a Solid dosage forms |0 https://id.loc.gov/authorities/subjects/sh85124623 |x Testing |0 https://id.loc.gov/authorities/subjects/sh99005648 |x Documentation |0 https://id.loc.gov/authorities/subjects/sh99005687 |z United States. |0 https://id.loc.gov/authorities/names/n78095330-781. | |
650 | 0 | |a Drugs |x Therapeutic equivalency |0 https://id.loc.gov/authorities/subjects/sh85039756 |x Documentation |0 https://id.loc.gov/authorities/subjects/sh99005687 |z United States. |0 https://id.loc.gov/authorities/names/n78095330-781. | |
710 | 2 | |a Center for Drug Evaluation and Research (U.S.) |0 https://id.loc.gov/authorities/names/n88077221. | |
856 | 4 | 0 | |u https://purl.fdlp.gov/GPO/LPS121078 |
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948 | |a MARCIVE Comp, 12/2021 | ||
948 | |a MARCIVE Over, 02/2021 | ||
948 | |a MARCIVE Comp, 2018.05 | ||
948 | |a MARCIVE August, 2017 | ||
948 | |a MARCIVE extract Aug 5, 2017 | ||
995 | |a Loaded with m2btab.ltiac in 2022.12 | ||
995 | |a Loaded with m2btab.ltiac in 2021.12 | ||
995 | |a Loaded with m2btab.ltiac in 2021.02 | ||
995 | |a Loaded with m2btab.b in 2021.01 | ||
995 | |a Loaded with m2btab.ltiac in 2018.06 | ||
995 | |a Loaded with m2btab.ltiac in 2017.08 | ||
995 | |a OCLC offline update by CMU | ||
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