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Results 1 - 50 of 307  for Bainbridge State College

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1
Material Type:
Journal
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Drug safety newsletter.

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

Bethesda, Md. : Food and Drug Administration, Center for Drug Evaluation and Research 2007

Online access

2
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

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3
Material Type:
Book
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Guidance for industry, investigators, and reviewers : exploratory IND 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 2006

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4
Material Type:
Book
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Guidance for industry : estimating the maximum safe starting dose in initial clinical trials for therapeutics in adult healthy volunteers.

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

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5
Material Type:
Book
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Guidance for industry : safety testing of drug metabolites.

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

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6
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

7
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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8
Material Type:
Book
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Guidance for industry : changes to an approved NDA or ANDA, specifications, use of enforcement discretion for compendial changes.

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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9
Material Type:
Book
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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.

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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10
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

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11
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

12
Material Type:
Book
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Guidance for FDA staff and industry : marketed unapproved 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 2006

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13
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

14
Material Type:
Book
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Guidance for industry : handling and retention of BA and BE testing samples.

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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15
Material Type:
Book
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Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 7, Dissolution test general chapter.

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

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

Online access

16
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

17
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

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18
Material Type:
Book
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Guidance for industry : expiration dating and stability testing of solid oral dosage form drugs containing iron.

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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19
Material Type:
Book
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Guidance for industry : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.

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

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20
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

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21
Material Type:
Book
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Está enfermo uno de sus hijos? : No adivine. Lea las indicaciones.

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 2006

Online access

22
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

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

Online access

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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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

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 industry : bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action.

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

28
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

29
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

Online access

30
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

31
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

32
Material Type:
Book
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Guidance for industry : nonclinical safety evaluation of pediatric 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 2006

Online access

33
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

34
Material Type:
Book
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Guidance for industry : labeling guidance for OTC topical drug products for the treatment of vaginal yeast infections (vulvovaginal candidiasis).

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

35
Material Type:
Book
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Guidance for industry : clozapine tables, in vivo bioequivalence and in vitro dissolution testing.

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

36
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

37
Material Type:
Book
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Guidance for industry : noncontraceptive estrogen drug products for the treatment of vasomotor symptoms and vulvar and vaginal atrophy symptoms : recommended prescribing information for heatlh care providers and patient labeling.

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

38
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

39
Material Type:
Book
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Guidance for industry : photosafety testing.

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

40
Material Type:
Book
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Q4B evaluation and recommendation of pharmacopeoial texts for use in the ICH regions. Annex 5, Disintegration test general chapter.

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

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

Online access

41
Material Type:
Book
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Guidance for industry : drug master files for bulk antibiotic 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 Drug Evaluation and Research 1999

Online access

42
Material Type:
Book
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E 16 genomic biomarkers related to drug response : context, structure, and format of qualification 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 2009

Online access

43
Material Type:
Website
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Drugs@FDA.

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

Washington D.C. : U.S. Food and Drug Administration, Center for Drug and Evaluation Research 2004

Online access

44
Material Type:
Book
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Guidance for industry : SUPAC-IR/MR : immediate release and modified release solid oral 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 1999

Online access

45
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

46
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

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47
Material Type:
Book
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Guidance for industry : submission of summary bioequivalence data for ANDAs.

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

48
Material Type:
Journal
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News along the pike.

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

Rockville, Md. : Center for Drug Evaluation and Research 1996

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49
Material Type:
Book
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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.

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

Rockville, Md. : Center for Drug Evaluation and Research 1995

Online access

50
Material Type:
Book
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Guidance for industry : nasal spray and inhalation solution, suspension, and spray 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 2002

Online access

Results 1 - 50 of 307  for Bainbridge State College

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