筛选
科学数据
统计数据
共检索到54条 ,权限内显示50条;
\u2022\tRegulatory requirement for drug development and approval in United States: review
- 负责人：
- 关键词：
- 111701 Aboriginal and Torres Strait Islander Health 111001 Aged Care Nursing 111702 Aged Health Care 110301 Anaesthesiology 110901 Autonomic Nervous System 111501 Basic Pharmacology Biomarkers 110601 Biomechanics 111201 Cancer Cell Biology 111202 Cancer Diagnosis
- DOI：
- doi:10.6084/m9.figshare.3381274.v1
- 摘要：
- ABSTRACT:In this paper a brief history and an overview of the regulatory process for drug approval in the United States through illustrations of Investigational New Drug (INDs) Applications and New Drug Applications (NDAs), abbreviated new drug applications (ANDAs) and supplemental new drug applications (SNDAs) are provided. For INDs, the regulatory requirements for a well-designed protocol, the role and responsibility of institutional review boards, and the applicability of treatment INDs are discussed. For NDAs, issues regarding the application of expanded access, the submission of abbreviated NDAs for a generic drug, the submission of supplemental NDAs for labeling changes, and the role and responsibility of advisory committees are addressed. Along with this a brief description of review steps taken by FDA is provided.INTRODUCTION:HISTORY:The research, development, and approval of a drug productis a continuous but lengthy process involving drugdiscovery, laboratory development, animal studies, clinicaltrials, and regulatory registration. This lengthy process isnecessary to assure the effectiveness and safety of the drug product. In the United States, however, no regulations were put forth until the Pure Food and Drug Act was passed by Congress in 1906. The purpose of this act is to preventmisbranding and adulteration of food and drugs yet it doesnot give the government any authority to inspect food anddrugs. The act was amended in 1912 (the SherleyAmendment) to prohibit labeling medicines with false andfraudulent claims. In 1931, the United States Food andDrug Administration (FDA) was formed. The provisions ofthe FDA are intended to ensure that:
The Cat As A Naturally Occurring Model Of Renal Interstitial Fibrosis: Characterisation Of Primary Feline Proximal Tubular Epithelial Cells And Comparative Pro-Fibrotic Effects Of Tgf-Β1
- 负责人：
- 关键词：
- DOI：
- doi:10.5281/zenodo.1341887
- 摘要：
- e is known of feline renal cell biology. In other species, TGF-β1 signalling in the proximal tubular epithelium is thought to play a key role in the initiation
The Cat As A Naturally Occurring Model Of Renal Interstitial Fibrosis: Characterisation Of Primary Feline Proximal Tubular Epithelial Cells And Comparative Pro-Fibrotic Effects Of Tgf-Β1
- 负责人：
- 关键词：
- DOI：
- doi:10.5281/zenodo.1341886
- 摘要：
- e is known of feline renal cell biology. In other species, TGF-β1 signalling in the proximal tubular epithelium is thought to play a key role in the initiation
Data from: Conservation of the genome-wide recombination rate in white-footed mice
- 负责人：
- DOI：
- doi:10.5061/dryad.f2kh311
- 摘要：
- scale. To address this notable gap, we used immunofluorescent cytology to quantify genome-wide recombination rates in a wild population of male
Data from: Recruitment dynamics of ESCRT-III and Vps4 to endosomes and implications for reverse membrane budding
- 负责人：
- DOI：
- doi:10.5061/dryad.gn250
- 摘要：
- The ESCRT machinery mediates reverse membrane scission. By quantitative fluorescence lattice light-sheet microscopy, we have shown that ESCRT-III subunits polymerize rapidly on yeast endosomes, together with the recruitment of at least two Vps4 hexamers. During their 3-45 second lifetimes, the ESCRT-III assemblies accumulated 75-200 Snf7 and 15-50 Vps24 molecules. Productive budding events required at least two additional Vps4 hexamers. Membrane budding was associated with continuous, stochastic exchange of Vps4 and ESCRT-III components, rather than steady growth of fixed assemblies, and depended on Vps4 ATPase activity. An all-or-none step led to final release of ESCRT-III and Vps4. Tomographic electron microscopy demonstrated that acute disruption of Vps4 recruitment stalled membrane budding. We propose a model in which multiple Vps4 hexamers (four or more) draw together several ESCRT-III filaments. This process induces cargo crowding and inward membrane buckling, followed by constriction of the nascent bud neck and ultimately ILV generation by vesicle fission.
Data from: Asexual reproduction in introduced and native populations of the ant Cerapachys biroi
- 负责人：
- Kronauer, Daniel J. C.
- 关键词：
- Animal Mating/Breeding Systems Behavior/Social Evolution Evolution of Sex Invasive Species Insects Population Genetics - Empirical
- DOI：
- doi:10.5061/dryad.54c7h
- 摘要：
- t automixis with central fusion is the most likely underlying cytological mechanism. This is in accordance with what is known for other thelytokous
Data from: Spectroscopic analysis of myoglobin and cytochrome c dynamics in isolated cardiomyocytes during hypoxia and reoxygenation
- 负责人：
- DOI：
- doi:10.5061/dryad.qm96r
- 摘要：
- Raman microspectroscopy was applied to monitor the intracellular redox state of myoglobin and cytochrome c from isolated adult rat cardiomyocytes during hypoxia and reoxygenation. The nitrite reductase activity of myoglobin leads to the production of nitric oxide in cells under hypoxic conditions, which is linked to the inhibition of mitochondrial respiration. In this work, the subsequent reoxygenation of cells after hypoxia is shown to lead to increased levels of oxygen-bound myoglobin relative to the initial levels observed under normoxic conditions. Increased levels of reduced cytochrome c in ex vivo cells are also observed during hypoxia and reoxygenation by Raman microspectroscopy. The cellular response to reoxygenation differed dramatically depending on the method used in the preceding step to create hypoxic conditions in the cell suspension, where a chemical agent, sodium dithionite, leads to reduction of cytochromes in addition to removal of dissolved oxygen, and bubbling-N2 gas leads to displacement of dissolved oxygen only. These results have an impact on the assessment of experimental simulations of hypoxia in cells. The spectroscopic technique employed in this work will be used in the future as an analytical method to monitor the effects of varying levels of oxygen and nutrients supplied to cardiomyocytes during either the preconditioning of cells or the reperfusion of ischaemic tissue.
Data from: Sources of variability in cytosolic calcium transients triggered by stimulation of homogeneous uro-epithelial cell monolayers
- 负责人：
- DOI：
- doi:10.5061/dryad.mn8cs
- 摘要：
- Epithelial tissue structure is the emergent outcome of the interactions between large numbers of individual cells. Experimental cell biology offers
Data from: Evolution of long centromeres in fire ants
- 负责人：
- DOI：
- doi:10.5061/dryad.8ff71
- 摘要：
- 34 % of the chromosomes, in the red imported fire ant Solenopsis invicta. By comparison, cytological examination of Solenopsis geminata revealed
Data from: From cellular characteristics to disease diagnosis: uncovering phenotypes with supercells
- 负责人：
- DOI：
- doi:10.5061/dryad.v6st3
- 摘要：
- for current single-cell biology. We introduce an approach that identifies a disease phenotype from multiparameter single-cell measurements, which is based
