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Results 1 - 50 of 196  for Bainbridge State College

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1
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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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2
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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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3
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Book
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Guidance for industry : analytical procedures and methods validation, chemistry, manufacturing, and controls documentation.

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 2000

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4
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Book
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Demonstration of comparability of human biological products, incuding therapeutic biotechnology-derived products.

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

Rockville, MD : U.S. Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research 1996

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5
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Book
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Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records.

United States. Food and Drug Administration. Office of Regulatory Affairs.; Center for Biologics Evaluation and Research (U.S.); Center for Drug Evaluation and Research (U.S.); Center for Devices and Radiological Health (U.S.); Center for Food Safety and Applied Nutrition (U.S.); Center for Veterinary Medicine (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine 2002

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6
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Book
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Guidance for industry : nonclinical studies for the safety evaluation of pharmaceutical excipients.

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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7
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Book
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Guidance for industry : pharmacogenomic data submissions, companion evidence.

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

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

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8
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Book
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Guidance for industry : changes to an approved application for specified biotechnology and specified synthetic biological products.

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 : Center for Drug Evaluation and Research 1997

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9
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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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10
Material Type:
Book
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Guidance for industry : providing regulatory submissions in electronic format, general considerations.

Center for Biologics Evaluation and Research (U.S.); Center for Drug Evaluation and Research (U.S.); Center for Devices and Radiological Health (U.S.); Center for Food Safety and Applied Nutrition (U.S.); Center for Veterinary Medicine (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine 2003

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11
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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12
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

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13
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Book
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Guidance for industry : available therapy.

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 2004

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14
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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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15
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Book
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Guidance for industry : biological product deviation reporting for licensed manufacturers of biological products other than blood and blood components.

Center for Biologics 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 Biologics Evaluation and Research : Center for Drug Evaluation and Research 2006

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16
Material Type:
Book
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Guidance for industry : fast track drug development programs, designation, development and application review.

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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17
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

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18
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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

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19
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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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20
Material Type:
Book
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Guidance for industry, q & a : content and format of INDs for phase 1 studies of drugs, including well-characterized, therapeutic, biotechnology-derived products.

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 2000

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21
Material Type:
Book
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Guidance for industry : population pharmacokinetics.

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 1999

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22
Material Type:
Book
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Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, electronic copies of electronic records.

United States. Food and Drug Administration. Office of Regulatory Affairs.; Center for Biologics Evaluation and Research (U.S.); Center for Drug Evaluation and Research (U.S.); Center for Devices and Radiological Health (U.S.); Center for Food Safety and Applied Nutrition (U.S.); Center for Veterinary Medicine (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine 2002

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23
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

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24
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

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25
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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26
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

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27
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

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28
Material Type:
Book
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Guidance for industry : M4, organization of the CTD.

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 : 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

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30
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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31
Material Type:
Book
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Guidance for industry : 21 CFR, part 11, electronic records : electronic signatures, glossary of terms.

United States. Food and Drug Administration. Office of Regulatory Affairs.; Center for Biologics Evaluation and Research (U.S.); Center for Drug Evaluation and Research (U.S.); Center for Devices and Radiological Health (U.S.); Center for Food Safety and Applied Nutrition (U.S.); Center for Veterinary Medicine (U.S.)

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of Regulatory Affairs : Center for Biologics Evaluation and Research : Center for Drug Evaulation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine 2001

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32
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

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33
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

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34
Material Type:
Book
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Guidance for industry : manufacturing, processing, or holding active pharmaceutical ingredients.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); Center for Veterinary Medicine (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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35
Material Type:
Book
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Guidance for industry : fast track drug development programs, designation, development and application review.

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 2004

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36
Material Type:
Book
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Guidance for industry : Q8(R2) pharmaceutical 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 2009

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37
Material Type:
Book
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Q8(R1) pharmaceutical development revision 1.

Center for Biologics 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: Center for Biologics Evaluation and Research 2008?

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38
Material Type:
Book
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Guidance for industry : SPL standard for content of labeling technical Qs & As.

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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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

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40
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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41
Material Type:
Book
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Guidance for industry : premarketing risk assessment.

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 Rresearch 2005

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42
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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43
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

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44
Material Type:
Book
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Guidance for industry : bioanalytical method validation.

Center for Drug Evaluation and Research (U.S.); Center for Veterinary Medicine (U.S.)

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

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45
Material Type:
Book
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Guidance for industry : immunotoxicology evaluation of investigational new 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 Drug Evaluation and Research 2002

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46
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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47
Material Type:
Book
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Guidance for industry : consumer-directed broadcast advertisements, questions and answers.

Center for Drug Evaluation and Research (U.S.); Center for Biologics Evaluation and Research (U.S.); Center for Veterinary Medicine (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 : Center for Veterinary Medicine 1999

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48
Material Type:
Book
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Guidance for industry : IND meetings for human drugs and biologics, chemistry, manufacturing, and controls information.

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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49
Material Type:
Book
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Guidance for industry : PAT, a framework for innovative pharmaceutical development, manufacturing, and quality assurance.

Center for Drug Evaluation and Research (U.S.); Center for Veterinary Medicine (U.S.); United States. Food and Drug Administration. Office of Regulatory Affairs.

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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50
Material Type:
Book
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Guidance for industry : aerosol steroid product safety information in prescription drug advertising and promotional 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 1997

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