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Results 1 - 50 of 308  for Bainbridge State College

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1
Material Type:
annual
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Center for Drug Evaluation and Research update.

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

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2007

Online access

2
Material Type:
Book
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Guidance for industry : dissolution testing of immediate release solid oral dosage forms.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1997

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3
Material Type:
Book
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Manual del Centro para la Evaluacion e Investigacion de Farmacos

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

Rockville, Md. : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2001

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4
Material Type:
Book
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Guidance for industry : liposome drug products, chemistry, manufacturing, and controls ; human pharmacokinetics and bioavailablity ; and labeling documentation.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2002

Online access

5
Material Type:
Book
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Reviewer guidance : integration of study results to assess concerns about human reproductive and developmental toxicities.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2001

Online access

6
Material Type:
Book
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Guidance for industry : PAC-ATLS : postapproval changes, analytical testing laboratory sites.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1998

Online access

7
Material Type:
Book
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Guidance for industry : court decisions, ANDA approvals, and 180-day exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2000

Online access

8
Material Type:
Book
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Guidance for industry : acute bacterial otitis media, developing drugs for treatment.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2008

Online access

9
Material Type:
Book
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Guidance for industry : testing of glycerin for diethylene glycol.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2007

Online access

10
Material Type:
Book
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Guidance for industry : investigating out-of-specification test results (OOS) for pharmaceutical production.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2006

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11
Material Type:
Book
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Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 6, Uniformity of dosage units general chapter.

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

College Park, Md.? : Center for Drug Evaluation and Research 2008

Online access

12
Material Type:
Book
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Guidance for industry : food-effect bioavailability and fed bioequivalence studies.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2002

Online access

13
Material Type:
Book
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Frecuentes preguntas acerca de las drogas genéricas.

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

Rockville, Md. : Dept. of Health and Human Services, U.S. Food and Drug Administration, Center for Drug Evaluation and Research 2004

Online access

14
Material Type:
Book
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Guidance for industry and review staff : nonclinical safety evaluation of reformulated drug products and products intended for administration by an alternate route.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2008

Online access

15
Material Type:
Book
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Guidance : drug safety information, FDA's communication to the public.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2007

Online access

16
Material Type:
Book
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Guidance for industry : submitting and reviewing complete responses to clinical holds.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2000

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17
Material Type:
Book
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Guidance for industry : waiver of in vivo bioavailability studies for immediate-release soild oral dosage forms based on a biopharmaceutics classification system.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2000

Online access

18
Material Type:
Book
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Guidance for industry : 180-day exclusivity when multiple ANDAs are submitted on the same day.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2003

Online access

19
Material Type:
Book
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Guidance for industry : 180-day generic drug exclusivity under the Hatch-Waxman amendments to the Federal Food, Drug, and Cosmetic Act.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1998

Online access

20
Material Type:
Book
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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.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1997

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21
Material Type:
Book
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Guidance for industry : acute bacterial meningitis, developing antimicrobial drugs for treatment.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1998

Online access

22
Material Type:
Book
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Guidance for industry : carcinogenicity study protocol submissions.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2002

Online access

23
Material Type:
Book
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Guidance for industry : botanical drug products.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2004

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24
Material Type:
Book
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Guidance for industry : acute or chronic bacterial prostatitis, developing antimicrobial drugs for treatment.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1998

Online access

25
Material Type:
Book
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Guideline for submitting supporting documentation in drug applications for the manufacture of drug substances.

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

Rockville, Md. : Center for Drug Evaluation and Research, Food and Drug Administration, Dept. of Health and Human Services 1987

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26
Material Type:
Book
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Guidance : PET drug products, current good manufacturing practice (CGMP).

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2005

Online access

27
Material Type:
Book
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Guidance for hospitals, nursing homes and other health care facilities.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2001

Online access

28
Material Type:
Book
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Guidance for industry : national uniformity for nonprescription drugs : ingredient listing for OTC drugs.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1998

Online access

29
Material Type:
Book
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Guidance : expiration dating of unit-dose repackaged drugs, compliance policy guide.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2005

Online access

30
Material Type:
Book
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Guidance for industry : changes to an approved NDA or ANDA, questions and answers.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2001

Online access

31
Material Type:
Book
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Guidance for industry : SUPAC-SS : nonsterile semisolid dosage forms : manufacturing equipment addendum.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1998

Online access

32
Material Type:
Book
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Guidance for industry : incorporation of physical-chemical identifiers into solid oral dosage form drug products for anticounterfeiting.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2009

Online access

33
Material Type:
Book
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Guidance for industry : acute bacterial sinusitis, developing drugs for treatment.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2007

Online access

34
Material Type:
Book
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Reviewer guidance : validation of chromatographic methods.

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

Rockville, MD : Center for Drug Evaluation and Research 1994

Online access

35
Material Type:
Book
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Good laboratory practice regulations, questions and answers.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration 1998

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36
Material Type:
Book
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Guidance for industry : statistical aspects of the design, analysis, and interpretation of chronic rodent carcinogenicity studies of pharmaceuticals.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2001

Online access

37
Material Type:
Book
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Guidance for industry : genotoxic and carcinogenic impurities in drug substances and products, recommended approaches.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2008

Online access

38
Material Type:
Book
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Guidance for industry : powder blends and finished dosage units : stratified in-process dosage unit sampling and assessment.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2003

Online access

39
Material Type:
Book
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Guidance for industry : labeling for combined oral contraceptives.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2004

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40
Material Type:
Book
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Guidance for industry : antiviral product development, conducting and submitting virology studies to the agency.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2006

Online access

41
Material Type:
Book
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Guidance for industry : PET drug applications : content and format for NDAs and ANDAs, fludeoxyglucose F 18 injection, ammonia N 13 injection, sodium fluoride F 18 injection.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2000

Online access

42
Material Type:
Book
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Guidance for industry : changes to an approved NDA or ANDA.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2004

Online access

43
Material Type:
Book
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Guidance for industry : variations in drug products that may be included in a single ANDA.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1998

Online access

44
Material Type:
Book
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Guidance for industry : NDA's : impurities in drug substances.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 2000

Online access

45
Material Type:
Book
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Guidance for industry : single dose acute toxicity testing for pharmaceuticals.

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

Rockville, MD : Center for Drug Evaluation and Research 1996

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46
Material Type:
Book
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Guidance for industry : metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products ; chemistry, manufacturing, and controls documentation.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1998

Online access

47
Material Type:
Book
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Guidance for industry : orally disintegrating tablets.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2008

Online access

48
Material Type:
Book
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Guidance for industry : community-acquired bacterial pneumonia : developing drugs for treatment.

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

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2009

Online access

49
Material Type:
Book
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Guidance for industry : label comprehension studies for nonprescription drug products : draft guidance.

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

Beltsville, Md. : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2009

Online access

50
Material Type:
Book
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Guidance for industry - dosage delivery devices for OTC liquid drug products.

Center for Drug Evaluation and Research (U.S.), issuing body.

Rockville, Md. : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2011

Online access

Results 1 - 50 of 308  for Bainbridge State College

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