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Results 1 - 50 of 308  for Bainbridge State College

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Result Number Material Type Add to My Shelf Action Record Details and Options
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 : format and content for the CMC section of an annual report.

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

Rockville, MD : Center for Drug Evaluation and Research 1994

Online access

3
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

4
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

Online access

5
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

6
Material Type:
Book
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Guidance for industry and review staff : recommended approaches to integration of genetic toxicology study results.

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

7
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

8
Material Type:
Book
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Guidance for industry : residual solvents in drug products marketed in the United States.

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

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9
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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10
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

11
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

Online access

12
Material Type:
Book
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Guidance for industry : Prescription Drug Marketing Act, donation of prescription drug samples to free clinics.

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

13
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

Online access

14
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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15
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

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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 : 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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18
Material Type:
Book
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Guidance for industry : statistical approaches to establishing bioequivalence.

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

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 : 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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21
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

22
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

23
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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24
Material Type:
Book
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Guidance for industry : hypertension indication, drug labeling for cardiovascular outcome claims.

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 2008

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25
Material Type:
Book
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Guideline for the format and content of the microbiology section of an application.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration 1990

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26
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

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27
Material Type:
Book
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Piénselo muy bien : una guía para el control de los beneficios y riesgos de las medicinas.

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

Rockville, Md.? : Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 2005

Online access

28
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

29
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

30
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

31
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

32
Material Type:
Book
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Guidance : topical dermatologic corticosteroids, in vivo bioequivalence.

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

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration 1995

Online access

33
Material Type:
Book
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Guidance for industry : antibacterial drug products, use of noninferiority studies to support approval.

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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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 : 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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36
Material Type:
Book
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Guidance for industry : public availability of labeling changes in "changes being effected" supplements.

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

37
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

38
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

39
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

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40
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

41
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

42
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

43
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

44
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

45
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

46
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

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47
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

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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 : 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

50
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

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