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Results 1 - 50 of 78  for Bainbridge State College

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1
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Book
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Quality of biotechnological products stability testing of biotechnological/biological products.

United States. Food and Drug Administration.; International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration 1996

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2
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Book
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Principles for clinical evaluation of new antihypertensive drugs.

United States. Food and Drug Administration.; International Conference on Harmonisation.

Rockville, MD? : U.S. Dept. of Health and Human Services, Food and Drug Administration 2000

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3
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Book
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Pharmacokinetics guidance for repeated dose tissue distribution studies.

United States. Food and Drug Administration.; International Conference on Harmonisation.

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

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4
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Book
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Post-approval safety data management : definitions and standards for expedited reporting.

United States. Food and Drug Administration.; International Conference on Harmonisation.

Rockville, Md.? : U.S. Dept. of Health and Human Services, Food and Drug Administration 2003

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5
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Book
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The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of of non-life threatening conditions.

United States. Food and Drug Administration.; International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1995

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6
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Book
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Clinical safety data management : definitions and standards for expedited reporting.

United States. Food and Drug Administration.; International Conference on Harmonisation.

Rockville, Md. : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research 1995

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7
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Book
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Text on validation of analytical procedures

United States. Food and Drug Administration.; International Conference on Harmonisation.

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

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8
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Book
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Detection of toxicity to reproduction for medicinal products

United States. Food and Drug Administration.; International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration 1994

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9
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Book
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Toxicokinetics the assessment of systemic exposures in toxicity studies.

United States. Food and Drug Administration.; International Conference on Harmonisation.

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

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10
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Book
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Addendum to ICH S6 : preclinical safety evaluation of biotechnology-derived pharmaceuticals.

United States. Food and Drug Administration.; International Conference on Harmonisation.

Rockville, Md.? : U.S. Dept. of Health and Human Services, Food and Drug Administration 2009

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11
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Book
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Q4B, annex 2, evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on test for extractable volume of parenteral preparations general chapter / International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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

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12
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Book
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Guidance for industry : granularity document : annex to M4, organization of the CTD.

Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2005

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13
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Book
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Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Dissolution Test General Chapter.

International Conference on Harmonisation. Center for Biologics Evaluation and Research (U.S.)

Rockville, Md.? : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research 2008

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14
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Book
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Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Sterility Test General Chapter.

International Conference on Harmonisation. Center for Biologics Evaluation and Research (U.S.)

Rockville, Md.? : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research 2008

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15
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Book
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Studies in support of special populations, geriatrics.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Center for Drug Evaluation 1994

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16
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Book
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Guidance for industry : M4Q, the CTD, quality.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

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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17
Material Type:
Book
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S2(R1) genotoxicity testing and data interpretation for pharmaceuticals intended for human use.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

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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18
Material Type:
Book
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Structure and content of clinical study reports.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, Md : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1996

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19
Material Type:
Book
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S9 nonclinical evaluation for anticancer pharmaceuticals.

International Conference on Harmonisation. Center for Biologics Evaluation and Research (U.S.)

Rockville, Md.? : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research 2009

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20
Material Type:
Book
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Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on Uniformity of Dosage Units, General Chapter.

International Conference on Harmonisation. Center for Biologics Evaluation and Research (U.S.)

Rockville, Md.? : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research 2008

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21
Material Type:
Book
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Quality of biotechnological products : analysis of the expression construct in cells used for production of r-DNA derived protein products.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1996

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22
Material Type:
Book
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Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

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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23
Material Type:
Book
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Dose-response information to support drug registration.

Center for Drug Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research 1994

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24
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Book
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Guidance for industry : Q1D bracketing and matrixing designs for stability testing of new drug substances and products.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2003

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25
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Book
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Guidance for industry : S7B nonclinical evaluation of the potential for delayed ventricular repolarization (QT Interval Prolongation) by human pharmaceuticals.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2005

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26
Material Type:
Book
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Guidance for industry : E6 good clinical practice, consolidated guidance.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Control : Center for Biologics Evaluation and Research 1996

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27
Material Type:
Book
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Guidance for industry : Q7A good manufacturing practice guidance for active pharmaceutical ingredients.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2001

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28
Material Type:
Book
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Guidance for industry E 10 choice of control group and related issues in clinical trials.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2001

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29
Material Type:
Book
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Guidance for industry : M4, the CTD, efficacy questions and answers.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2004

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30
Material Type:
Book
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Guidance for industry : E9 statistical principles for clinical trials.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 1998

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31
Material Type:
Book
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Guidance for industry : S1B testing for carcinogenicity of pharmaceuticals.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 1997

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32
Material Type:
Book
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Guidance for industry : Q6B specifications : test procedures and acceptance criteria for biotechnological /biological products.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 1999

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33
Material Type:
Book
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Guidance for industry : M4S, the CTD, safety.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2001

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34
Material Type:
Book
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Guidance for industry : Q1C stability testing for new dosage forms.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 1996

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35
Material Type:
Book
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Guidance for industry M2, eCTD specification, questions & answers and change requests.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2005

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36
Material Type:
Book
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Guidance for industry : Q1B photostability testing of new drug substances and products.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 1996

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37
Material Type:
Book
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Guidance for industry : E 11 clinical investigation of medicinal products in the pediatric population.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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

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38
Material Type:
Book
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Guidance for industry : S6 preclinical safety evaluation of biotechnology-derived pharmaceuticals.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 1997

Online access

39
Material Type:
Book
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Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions : annex 2 test for extractable volume of parenteral preparations general chapter.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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

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40
Material Type:
Book
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Guidance for industry : S1C(R2) dose selection for carcinogenicity studies.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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

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41
Material Type:
Book
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Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions, annex 1, residue on ignition/sulphated ash, general chapter.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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

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42
Material Type:
Book
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Guidance for industry : E15 definitions for genomic biomarkers, pharmacogenomics, pharmacogenetics, genomic data and sample coding categories.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evalutation and Research CDER ; Rockville, MD : Center for Biologics Evaluation and Research CBER 2008

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43
Material Type:
Book
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E2f development safety update report.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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

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44
Material Type:
Book
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Guidance for industry : M2 eCTD : electronic common technical document specification.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2003

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45
Material Type:
Book
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Guidance for industry : Q8 pharceutical development.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2006

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46
Material Type:
Book
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Guidance for industry Q3A impurities in new drug substances.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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

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47
Material Type:
Book
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Guidance for industry : Q2B validation of analytical procedures, methodology.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 1996

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48
Material Type:
Book
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Guideline for industry : detection of toxicity to reproduction for medicinal products, addendum on toxicity to male fertility.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

Rockville, MD : Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research 1996

Online access

49
Material Type:
Book
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Guidance for industry Q3A impurities in new drug substances.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2008

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50
Material Type:
Book
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Guidance for industry : S7A safety pharmacology studies for human pharmaceuticals.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); International Conference on Harmonisation.

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 2001

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