Transmittal of Labels and Circulars: FDA Form 2567

Known as: 1.1.6, Form FDA 2567: Transmittal of Labels and Circulars 
A form used when submitting draft, revised or final labeling to a BLA.(eCTD)

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1986-2017
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Review
2016
Review
2016
MANET is infrastructure less, decentralized multi hope network where the nodes are randomly to move in any direction, there each… (More)
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2014
2014
  • 2014
1 Sigma-Algebra: Describing measurable sets 7 1.1 Families of sets . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.1.1… (More)
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2014
2014
  • 2014
1 Sigma-Algebra: Describing measurable sets 6 1.1 Families of sets . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.1.1… (More)
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Review
2014
Review
2014
.................................................................................................................................... 9 1. REVIEW OF THE LITERATURE .............................................................................................. 11 1.1. Periodontal disease ................................................................................................... 11 1.1.1. Structure of the periodontium ..................................................................... 11 1.1.2. Classification of periodontal disease ............................................................ 12 1.1.3. Pathogenesis of periodontitis ....................................................................... 13 1.1.4. Host response ............................................................................................... 14 1.1.5. Genetic susceptibility to periodontitis .......................................................... 17 1.1.6. Definition of periodontitis ............................................................................ 20 1.1.7. Prevention and treatment of chronic periodontitis ..................................... 21 1.2. Lipoprotein metabolism ............................................................................................ 22 1.2.1. Lipoproteins .................................................................................................. 22 1.2.2. Lipoprotein metabolism and lipid transport ................................................. 24 1.3. Lipopolysaccharide .................................................................................................... 26 1.3.1. Structure of LPS............................................................................................. 26 1.3.2. LPS-mediated signaling and the innate immune response .......................... 26 1.3.3. LPS and periodontitis .................................................................................... 27 1.3.4. LPS and nutrition ........................................................................................... 28 1.4. Cardiometabolic disorders ........................................................................................ 29 1.4.1. Atherosclerosis and cardiovascular diseases ................................................ 29 1.4.2. Obesity, metabolic syndrome, and diabetes mellitus .................................. 32 1.5. Periodontitis and cardiometabolic disorders ............................................................ 34 1.5.1. Periodontitis and cardiovascular diseases .................................................... 34 1.5.2. Periodontitis and obesity, MetS, and diabetes ............................................. 37 2. AIMS OF THE STUDY ............................................................................................................ 39 3. STUDY SUBJECTS AND METHODS ....................................................................................... 40 3.1. Study subjects and design ......................................................................................... 40 3.1.1. The Parogene study (I) .................................................................................. 40 3.1.2. The Health 2000 Survey (I) ............................................................................ 40 3.1.3. Periodontitis treatment study in Sweden (II) ............................................... 41 3.1.4. Periodontitis treatment study in Finland (III) ............................................... 41 3.1.5. The FINRISK97 Study (IV) .............................................................................. 41 3.2. Methods .................................................................................................................... 43 3.2.1. Periodontal examination and treatment (I, II, III) ......................................... 44 3.2.2. Genotyping (I) ............................................................................................... 45 3.2.3. Histological analysis and immunohistochemistry (I) .................................... 46 3.2.4. Isolation of lipoproteins (II, III)...................................................................... 46 3.2.5. Serum LPS activity determinations (II, III, IV)................................................ 47 3.2.6. Cell culture (III) .............................................................................................. 47 3.2.7. cDNA synthesis and quantitative real-time PCR (III) .................................... 48 3.2.8. Statistical analysis (I, II, III, IV) ....................................................................... 49 4. RESULTS ............................................................................................................................... 51 4.1. Genetics predisposing to periodontitis (I)................................................................. 51 4.2. Endotoxemia in patients with periodontitis (II, III) ................................................... 54 4.2.1. Plasma LPS activity and lipoprotein distribution in periodontitis patients before and after periodontal treatment (II) ................................... 54 4.2.2. Proatherogenic properties of VLDL isolated from periodontitis patients before and after periodontal treatment (III) ................................................ 55 4.3. Endotoxemia and nutrition in patients with cardiometabolic disorders (IV) ........... 59 5. DISCUSSION ......................................................................................................................... 63 5.1. Genetic basis of periodontitis ................................................................................... 63 5.2. Periodontal parameters and definition of periodontitis .......................................... 64 5.3. Proinflammatory mediators ...................................................................................... 65 5.4. The effects of periodontitis-induced endotoxemia on lipoproteins ......................... 66 5.5. Local and systemic effects of periodontal treatment ............................................... 68 5.6. Endotoxemia, cardiometabolic disorders, and diet .................................................. 69 5.7. Challenges in the determination of LPS activity ....................................................... 70 6. CONCLUSIONS ..................................................................................................................... 72 ACKNOWLEDGEMENTS .............................................................................................................. 75 REFERENCES ............................................................................................................................... 77 
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2013
2013
.................................................................................................................................III Table of contents......................................................................................................................V Abbreviations......................................................................................................................... IX General Introduction .............................................................................................................. 1 Chapter 1 State of Art............................................................................................................. 5 1.1. Cancer diagnosis ............................................................................................... 9 1.1.1. Key data related to cancers.......................................................................9 1.1.2. Tumorigenesis ....................................................................................... 10 1.1.3. Conventional techniques for cancer detection ......................................... 13 1.1.4. Techniques in development.................................................................... 16 1.1.5. Breast cancer ......................................................................................... 17 1.1.6. Colorectal cancer ................................................................................... 21 1.2. Protein microarray......................................................................................... 25 1.2. 
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2011
2011
Equity Payout is ‘Net dividends of nonfarm, nonfinancial business’ (Table F.102, line 3), plus ‘Net dividends of farm business… (More)
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Highly Cited
2008
Highly Cited
2008
This paper presents the R/Bioconductor package minet (version 1.1.6) which provides a set of functions to infer mutual… (More)
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2007
2007
1.1.6 Let p(•) be any polynomial. If λ ∈ σ(A) with associated eigenvector y, then p(λ) ∈ σ(p(A)) also with associated eigenvector… (More)
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Highly Cited
2003
Highly Cited
2003
To the memory of my parents, Sara and Avraham Haviv To my mother and late father, Fela and Shimon Hassin Contents Preface xi 1… (More)
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Review
1999
Review
1999
interpretation Loop: Parse bytecode Update state Rectify state with Successor basic blocks Main Initialization Choose basic block… (More)
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