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1
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Guidance for industry considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications.

Center for Biologics 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 2006

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2
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Guidance for industry considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications.

Center for Biologics 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 2006

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3
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Guidance for industry : providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format, lot release protocols.

Center for Biologics 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 2007

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4
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Guidance for industry : general principles for the development of vaccines to protect against global infectious diseases.

Center for Biologics 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 2008

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5
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Guidance for industry : Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue based products (HCT/Ps).

Center for Biologics 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 2009

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6
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Guidance for industry : requalification method for reentry of blood donors deferred because of reactive test results for antibody to hepatitis B core antigen (anti-HBc).

Center for Biologics 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 2008

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7
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Guidance for industry : validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products.

Center for Biologics 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 2008

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8
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Guidance for industry : nucleic acid testing (NAT) to reduce the possible risk of parvovirus B19 transmission by plasma-derived products.

Center for Biologics 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 2008

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9
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Guidance for industry : considerations for allogeneic pancreatic islet cell products.

Center for Biologics 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 2008

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10
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Guidance for industry : certain human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered from donors who were tested for communicable diseases using pooled speciments or diagnostic tests.

Center for Biologics 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 2008

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11
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Guidance for industry and FDA staff : class II special controls guidance document : automated blood cell separator device operating by centrifugal or filtration separation principle.

Center for Biologics 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 2007

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12
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Book
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PDUFA pilot project : proprietary name review.

Center for Biologics 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 2008

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13
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Book
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Guidance for industry : potency tests for cellular and gene therapy products.

Center for Biologics 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 2008

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14
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Guidance for industry : "computer crossmatch" (electronic based testing for the compatibility between the donor's cell type and the recipient's serum or plasma type).

Center for Biologics 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 2007

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15
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Book
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Guidance for industry : class II special controls guidance document : in vitro HIV drug resistance genotype assay.

Center for Biologics 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 2007

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16
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Guidance for industry : safety, efficacy, and pharmacokinetic studies to support marketing of immune globuline intravenous (human) as replacement therapy for primary humoral immunodeficiency.

Center for Biologics 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 2008

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17
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Book
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Guidance for industry Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2008

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18
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Book
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Guidance for industry : tropical disease priority review vouchers.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 CDER ; Rockville, MD : Center for Biologics Evaluation and Research CBER 2008

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19
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Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 4B, Microbiological examination of nonsterile products : tests for specified microorganisms general chapter.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2009

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20
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Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. 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.)

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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21
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Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 3, Test for particulate contamination : subdivisible particles general chapter.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2009

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22
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Book
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Guidance for industry : Q5E comparability of biotechnological/biological products subject to changes in their manufacturing process.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2005

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23
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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24
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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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25
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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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26
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Book
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Guidance for industry : dosage and administration section of labeling for human prescription drug and biological products, content and format.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2007

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27
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Book
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Guidance for industry and review staff : labeling for human prescription drug and biological products : determining established pharmacologic class for use in the highlights of prescribing information.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 ; Rockville, MD : Center for Biologics Evaluation and Research 2009

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28
Material Type:
Book
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Guidance for industry : labeling for human prescription drug and biological products, implementing the new content and format requirements.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2006

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29
Material Type:
Book
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Draft guidance for HDE holders, institutional review boards (IRBs), clinical investigators, and FDA staff : humanitarian device exemption regulation, questions and answers.

Center for Devices and Radiological Health (U.S.); Center for Biologics Evaluation and Research (U.S.)

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

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30
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Book
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Guidance for industry : cooperative manufacturing arrangements for licensed biologics.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 ; Silver Spring, MD : Center for Drug Evaluation and Research 2008

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31
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Book
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Modifications to devices subject to premarket approval (PMA) : the PMA supplement decision-making process.

Center for Devices and Radiological Health (U.S.); Center for Biologics Evaluation and Research (U.S.)

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

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32
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Book
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Guidance for industry : Q9 quality risk management.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2006

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33
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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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34
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Book
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Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 4C, Microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2009

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35
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Book
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Guidance for industry : animal models : essential elements to address efficacy under the animal rule.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 CDER : Center for Biologics Evaluation and Research CBER 2009

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36
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Book
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Guidance for industry : content and format for geriatric labeling.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2001

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37
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Book
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Guidance for industry : contents of a complete submission for the evaluation of proprietary names.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 CDER ; Rockville, MD : Center for Biologics Evaluation and Research CBER 2008

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38
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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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39
Material Type:
Book
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Guidance for industry : submitting marketing applications according to the ICH-CTD format, general considerations.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2001

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40
Material Type:
Book
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Guidance for industry : Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH region. Annex 4A, Microbiological examination of nonsterile products : microbial enumeration tests general chapter.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2009

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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 region. 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.)

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 2009

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42
Material Type:
Book
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Guidance for industry : indexing structured product labeling.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2008

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43
Material Type:
Book
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Animal models : essential elements to address efficacy under the animal rule.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2008

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44
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Book
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Guidance for industry : drug-induced liver injury, premarketing clinical evaluation.

Center for Drug Evaluation and Research (U.S.); Center for Biologics 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 : Center for Biologics Evaluation and Research 2007

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45
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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46
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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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47
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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

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48
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Book
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Guidance for industry : E2E pharmacovigilance planning.

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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49
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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50
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Book
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Guidance for industry : addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs.

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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