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• Title:Software innovations in clinical drug development and safety / [edited by] Partha Chakraborty, Amit Nagal.
  
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• Other Contributors/Collections:Chakraborty, Partha, 1972- editor.
  Nagal, Amit, 1979- editor.
  
• Published/Created:Hershey, PA : Medical Information Science Reference, [2016]
  ©2016
  

• Holdings

  Holdings Record Display

  • Location:WOODWARD LIBRARY stacksWhere is this?
    
  • Call Number: QV26.5 .S637 2016
    
  • Number of Items:1
    
  • Status:Available
    

   
• Library of Congress Subjects:Pharmacy informatics.
  Drug development--Technological innovations.
  
• Medical Subjects: Drug Discovery.
  Software.
  Clinical Trials as Topic.
  Genomics.
  Pharmacovigilance.
  
• Description:xiv, 305 pages : illustrations ; 29 cm
  
• Series:Advances in medical technologies and clinical practice book series.
  
• Summary:"This book is a comprehensive resource analyzing the integration of software engineering for the purpose of drug discovery, clinical trials, genomics, and drug safety testing"--Provided by publisher.
  
• Notes:Includes bibliographical references and index.
  
• ISBN:9781466687264 hardcover
  1466687266 hardcover
  9781466687271 electronic book
  
• Contents:Machine generated contents note: overall process of getting a drug to the market is a long one and takes 10-15 years and costing close to a billion dollar. The success rate as the compound travels from the initial discovery phase to clinical and then through to the market is about 1 in 10,000. The two key phases which together contribute the most to the cost and timeline are clinical development and pharmacovigilance. These two phases together also account for the maximum number of failures. In this chapter, we will look in detail at these two phases with a focus on the business process and process areas which have application of computer systems. The chapter will focus on looking at the various phases of clinical development and their endpoints. Clinical development is the process of testing a drug for safety and efficacy in human subjects. Clinical trial is conducted in 3 phases with the 4th phase which is ongoing post approval which forms an important part of the pharmacovigilance process. These phases will be elaborated in [ect.] / Sowmyanarayan Srinivasan
  This chapter contains as well as illustrates different innovations that is changing the way Clinical Drug Development and Safety organizations perceives IT and the ways and means through which these innovations are facilitating the change in business itself. The main content contains illustrations of two structurally different means to create data warehouses, the benefits of the approaches and the difficulties. It also explains the importance of data virtualization technology when implemented in the Clinical and Safety [ect.] / Kanishka Mukherjee
  This chapter talks about metadata repository, and master data management in clinical trial and drug safety. The chapter begins with the definition of metadata repository and gives an explanation around the same, It talks about a well designed metadata repository and the characteristics associated with the same. A brief around why we need metadata and the reasons for the using the same has also been mentioned. The benefits of a well structured metadata repository was also mentioned in detail. The chapter then gives a detailed explanation on master data management and the usage of MDM in clinical trials. MDM solutions for clinical trials management is also explained in [ect.] / Chandrakant Ekkirala
  Semantic technologies have gained prominence over the last several years. Semantic technologies are explored in detail and semantic integration of data will be outlined. The various data integration techniques and approaches will also be touched upon. Text Mining, different associated algorithms and the various tools and technologies used in text mining will be enumerated in detail. The chapter will have the following sections [
  ]1. Data Integration Techniques [[TM]] Data Integration Technique [
  ] Extraction, Transformation and Loading (ETL) [[TM]] Data Integration Technique [
  ] Data Federation 2. Data Integration Approaches [[TM]] Need Based Data Integration [[TM]] Periodic Data Integration [[TM]] Continuous Data Integration 3. Semantic Integration 4. Semantic Technologies 5. Semantic Web Technologies 6. Text Mining 7. Text Mining Algorithms 8. Tools and Technologies for Text [ect.] / Chandrakant Ekkirala
  Drug development is a complex set of inter-linked processes in which the cumulative understanding of a drug's safety and efficacy profile is shaped during different learning phases. Often, drugs are approved based on limited safety information, for example in highly at risk or rare disease populations. Therefore, post approval, regulatory organizations have mandated proactive surveillance strategies that include the collection of reported adverse events experienced by exposed populations, some of whom may have been on treatment for extended periods of time. Analyzing these accumulating adverse event reports to understand their clinical significance, given the limitations imposed by the methods of data collection, is a complicated task. The aim of this chapter is to provide the readers with a general understanding of safety signal detection and assessment, followed by a description of statistical methods (both classical and Bayesian) typically utilized for quantifying the strength of association between a drug and an adverse [ect.] / Antoni F.Z. Wisniewski / Ramin B. Arani
  current digital age is primarily driven by four technology forces namely, Social Media, Mobility, Analytics and Cloud computing. These technologies continue to evolve and shape the digital world, giving people and businesses newer experiences and opportunities that they were not exposed to in the past. Digital technology has the potential to change the world significantly which in turn has a disruptive impact in the world of business. Hence, 'digitizing' its business must be one of top priorities in the medium and long term of every business to ensure a successful future. This chapter begins with by defining each of the four technologies, its benefits and what it means to the key stakeholders in the healthcare business. It also covers many use cases of SMAC with a specific focus on clinical development and pharmacovigilance. The later part of the chapter lays the foundation for setting up a SMAC organization including key strategies, conceptual framework, technology and regulatory compliance [ect.] / Manu Venugopal
  Collaboration is defined as the actions for individuals and teams to work together for a common goal. There are several bottlenecks to an efficient and effective collaborative model of clinical trial including: the lack of a centralized, consistent, globally accessible platform to manage and store essential study related documentation; inconsistent or incomplete work assignments; inefficient notification of key events requiring follow-on action; and incomplete, missing, expired, or redundant documentation and training activities and need to maintain multiple credential to access various system, Removing these barriers is an important part of establishing an environment that fosters collaboration among all constituencies involved in managing clinical trial keeping them connected, informed, and on task by providing access to everyone at any time, from anywhere. The case study below introduces need of an integrated clinical collaboration platform, addressing key functionality of such an platform and describes the architecture & design consideration to industrialize such a platform. The intended audience of this case study is the architects & designers of similar systems. The clinical trial activity for a drug in research is approximately 70% of the overall drug development cost. It is estimated that 4% of the cost of a trial is in 'rework' involving communication, regulatory issues, patient enrollment, document review and replacement of patients. The integrated clinical collaboration platform has potential to eliminate significant amount of cost of re-work, which is in order of $3.5M per [ect.] / Partha Chakraborty
  pharmaceutical and medical manufacturing sectors have entered a period of disruptive transformation in the way regulatory affairs are conducted globally. The global clinical and regulatory landscape is evolving more quickly in this decade than ever before. The advent of adaptive trial designs, rolling submissions for indications, as well as the impact of regulatory policies in emerging markets, are influencing Pharma's ability to secure approvals efficiently and effectively and with required emphasis on safety and compliance. The impact of these changes on Regulatory Information Management can be significant over the next 5-7 years. Companies are rightfully asking what the transformation in business processes and technology might look like and what types of innovations they can adopt now to prepare them for the future state. The case study below introduces the need for an integrated Regulatory Information Management (RIM) platform, addressing key functionality of such an environment and describes the architecture & design consideration to industrialize such a [ect.] / Ayan Choudhury
  DNA sequencing is the process to identification of nucleotides order in genome which developed from very broad history, also it is derived from version of the Sanger biochemistry. SOLiD, 454 and Polonator sequencing based on emulsion PCR to amplify clonal sequencing with in-vitro construction of adaptor-flanked shotgun library, PCR amplified in the context of a water-in-oil emulsion. Solexa technology relies on bridge PCR to amplify clonal sequencing features. At the conclusion of the PCR, each clonal cluster contains [
  ]1,000 copies of a single member of the template library. This chapter focused on next-generation sequencing technologies methods, capabilities and clinical applications of DNA sequencing technologies for researchers in molecular biology and physician scientists. This will also provide the power of these novel genomic tools and methods to use personal diagnostic at molecular [ect.] / Udayaraja G.K.
  Contents note continued: Pharmacogenomics deals with drug responses in individual based on genetic variation in genome. Based on genetic variations, drugs may produce more or less therapeutic effect, and same way in side effects also. Physicians can use information about your genetic makeup to choose those drugs and drug doses to get better therapy. Optimizing drug therapy and rational dose adjustment with respect to genetic makeup will maximize drug efficacy and minimal adverse effects. This broken traditional 'trial and error' method of 'one drug fits all', and 'one dose fits all' which contributing to 25-50% of drug toxicity or treatment failures. This will contribute to improve the ways in which existing drugs are used, genomic research will lead to drug development to produce new drugs that are highly effective without serious side effects. This approach to bring personalized medicine more practice and drug combinations are optimized for each individual' genetic [ect.] / Udayaraja G.K.
  Epigenetics is the study of changes in organisms caused by modification of gene expression rather than alteration of the genetic code itself. ChIP-seq, is a method used to analyze protein interactions with DNA. It is a type of epigenetic analysis technique. Chromatin immunoprecipitation coupled with massive parallel sequencing (ChIP-seq) is gaining popularity day by day because of its clinical significance. It is a very effective tool in diagnosis of disease such as cancer. ChIP-seq is found to be very effective tool in understanding basic regulatory mechanism, cell differentiation study and studying disease processes with the decreasing cost of sequencing, ChIP-seq has become an indispensable tool for studying gene regulation and epigenetic mechanisms. The Present review explores epigenetic methods, pipeline and its role in [ect.] / Amit Nagal
  Recent advances in human exome sequencing and the associated advantages have made it a technology of choice in various domains. The savings in time, cost and data storage compared with whole genome sequencing make this technology a potential game changer in clinical research settings. Recent advances in NGS have made it feasible to use exome sequencing in clinical research for identifying novel and rare variants that can lead to change in protein structure and function which may finally culminate into a totally different phenotype. If whole exome is not desired the same technology can be used for studying target exonic regions to investigate causative genes for a specific phenotype associated with disease. Exome sequencing has emerged as an effective and efficient tool for the translational and clinical research. There is a demand for systematically storing variant information in large databanks. Meaningful information from the exome-seq data can be combined with other data. This can be correlated with clinical findings within a clinical trial setting for a better study [ect.] / Geethanjali Tanikella / Sushma Patil / Jasmine Khurana / Brajendra Kumar / Shibichakravarthy Kannan / Anu Acharya
  Given that Agile software development is preferred methodology for products and services in life science industry, in this chapter we will describe how to adopt Agile software development process and still be compliant. We will focus on few Agile methodologies and provide details on what design controls we can adopt in order for the product and process to be compliant. We will also focus on some of the tools that can be used to help put such design and process control in place where we can have complete transparency and [ect.] / Arindam Dey / Yerramalli Subramaniam / Avik Pal.