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Center for Drug Evaluation and Research (U.S.)
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Documentation

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Current results range from 1987 to 2002

1.
Guidance for industry liposome drug products, chemistry, manufacturing, and controls; human pharmacokinetics and bioavailablity; and labeling documentation
Published
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2002]
Online
http://purl.access.gpo.gov/GPO/LPS120850
Location
Yale Internet Resource >> None
Format
Books / Online
2.
Guidance for industry analytical procedures and methods validation, chemistry, manufacturing, and controls documentation
Published
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, [2000]
Online
http://purl.access.gpo.gov/GPO/LPS120627
Location
Yale Internet Resource >> None
Format
Books / Online
3.
Guidance for industry nonsterile semisolid dosage forms : scale-up and postapproval changes : chemistry, manufacturing, and controls : in vitro release testing and in vivo bioequivalence documentation
Published
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997]
Online
http://purl.access.gpo.gov/GPO/LPS121136
Location
Yale Internet Resource >> None
Format
Books / Online
4.
Guidance for industry SUPAC-MR : modified release solid oral dosage forms : scale-up and postapproval changes, chemistry, manufacturing and controls, in vitro dissolution testing and in vivo bioequivalence documentation
Published
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997]
Online
http://purl.access.gpo.gov/GPO/LPS121122
Location
Yale Internet Resource >> None
Format
Books / Online
5.
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
Published
[Rockville, Md.] : Center for Drug Evaluation and Research, [1995]
Online
http://purl.access.gpo.gov/GPO/LPS121078
Location
Yale Internet Resource >> None
Format
Books / Online
6.
Guideline for submitting documentation for the manufacture of and controls for drug products
Published
Rockville, Md. : Center for Drugs and Biologics, Food amd [sic] Drug Administration, U.S. Dept. of Health and Human Services, [1987]
Online
http://purl.access.gpo.gov/GPO/LPS121022
Location
Yale Internet Resource >> None
Format
Books / Online
7.
Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances
Published
Rockville, Md. : Center for Drug Evaluation and Research, Food and Drug Administration, Dept. of Health and Human Services, [1987]
Online
http://purl.access.gpo.gov/GPO/LPS121075
Location
Yale Internet Resource >> None
Format
Books / Online