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1
2009
E-REPORT
Guidance for industry submission of summary bioequivalence data for ANDAs.
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2009]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
2
2007
E-REPORT
Guidance for industry bioequivalence recommendations for specific products.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2007]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
3
2005
E-REPORT
Guidance for industry potassium chloride modified-release tablets and capsules, in vivo bioequivalen
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2005]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
4
2005
E-REPORT
Guidance for industry clozapine tables, in vivo bioequivalence and in vitro dissolution testing.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2005]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
5
2004
E-REPORT
Guidance for industry handling and retention of BA and BE testing samples.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2004]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
6
2003
E-REPORT
Guidance for indusry bioavailability and bioequivalence studies for nasal aerosols and nasal sprays
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
7
2002
E-REPORT
Guidance for industry food-effect bioavailability and fed bioequivalence studies.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2002]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
8
2001
E-REPORT
Guidance for industry statistical approaches to establishing bioequivalence.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
9
2000
E-REPORT
Guidance for industry waiver of in vivo bioavailability studies for immediate-release soild oral dos
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2000]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
10
1999?
E-REPORT
Electronic orange book approved drug products with therapeutic equivalence evaluations.
[Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Information Technology, Division of Data Management and Services, <1999?- >

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
11
1997
E-REPORT
Guidance for industry SUPAC-MR : modified release solid oral dosage forms : scale-up and postapprova
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
12
1997
E-REPORT
Guidance for industry nonsterile semisolid dosage forms : scale-up and postapproval changes : chemis
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [1997]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
13
1995
E-REPORT
Guidance topical dermatologic corticosteroids, in vivo bioequivalence.
Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, [1995]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
14
1995
E-REPORT
Guidance for industry immediate release solid oral dosage forms : scale-up and postapproval changes,
[Rockville, Md.] : Center for Drug Evaluation and Research, [1995]

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic Report    AVAILABLE
15
1985-
MICROFORM
Approved drug products with therapeutic equivalence evaluations
[Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics ; Washington, D.C. : [For sale by the Supt. of Docs., U.S. G.P.O., 1985-

Copies / Volumes

LOCATION CALL # STATUS
 GovDocs Federal/Fiche  HE 20.4715:  2001    AVAILABLE
 GovDocs Federal/Fiche  HE 20.4715:  1999/SUPP. 12    AVAILABLE
 GovDocs Federal/Fiche  HE 20.4715:  2000    AVAILABLE
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16
 
E-PERIODICAL
Approved drug products with therapeutic equivalence evaluations
[Rockville, Md.] : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics

Copies / Volumes

LOCATION CALL # STATUS
 Internet  Electronic journal    AVAILABLE
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