Contract Research and Manufacturing Services CRAMS in India

The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the field of CRAMS. Following an overview of the services and their emergence in India, chapters in the book begin by discussing the legal and regulatory scenario and major concerns and issues. In the latter part of the book, topics covered include service agreements, dispute resolution and contract negotiations, followed by a discussion of the outlook for CRAMS in India and some concluding remarks. Several appendices are included, offering a list of major players in the field and various forms for use in licence applications. Simple and accessible presentation using tables, charts and diagrams Practical tips from leading practitioners Inclusion of relevant case laws and other legal considerations

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  • Author : Milind Antani
  • Publisher : Elsevier
  • Pages : 248 pages
  • ISBN : 1908818166
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKContract Research and Manufacturing Services CRAMS in India

Contract Research and Manufacturing Services (CRAMS) in India

Contract Research and Manufacturing Services (CRAMS) in India
  • Author : Milind Antani,Gowree Gokhale
  • Publisher : Elsevier
  • Release : 31 October 2012
GET THIS BOOKContract Research and Manufacturing Services (CRAMS) in India

The field of contract research and manufacturing broadly encompasses those services in the pharmaceutical and biotechnology sectors that require extensive research and development and large-scale manufacturing facilities. The field has great potential for growth in the Indian outsourcing industry, which is world-renowned for its provision of cheap and highly-skilled services. Contract research and manufacturing services (CRAMS) in India provides a detailed account of the current scenario in India and the advantages that the Indian outsourcing industry can offer in the

Clinical Research in Asia

Clinical Research in Asia
  • Author : U Sahoo
  • Publisher : Elsevier
  • Release : 25 May 2012
GET THIS BOOKClinical Research in Asia

Asia is increasingly taking on a leading role in the fields of Good Clinical Practice (GCP) and ethics, two areas that are central to clinical research practices worldwide. Clinical research in Asia examines the evolution of these key sectors in the Asian countries where the greatest developments are taking place, offering valuable perspectives on a wide range of issues affecting clinical research. Following an introduction that provides an overview of the topic and its strengths and weaknesses, each chapter of

Open Source Software in Life Science Research

Open Source Software in Life Science Research
  • Author : Lee Harland,Mark Forster
  • Publisher : Elsevier
  • Release : 31 October 2012
GET THIS BOOKOpen Source Software in Life Science Research

The free/open source approach has grown from a minor activity to become a significant producer of robust, task-orientated software for a wide variety of situations and applications. To life science informatics groups, these systems present an appealing proposition - high quality software at a very attractive price. Open source software in life science research considers how industry and applied research groups have embraced these resources, discussing practical implementations that address real-world business problems. The book is divided into four

NMR Metabolomics in Cancer Research

NMR Metabolomics in Cancer Research
  • Author : Miroslava Čuperlović-Culf
  • Publisher : Elsevier
  • Release : 17 December 2012
GET THIS BOOKNMR Metabolomics in Cancer Research

The application of nuclear magnetic resonance (NMR) metabolomics in cancer research requires an understanding of the many possibilities that NMR metabolomics can offer, as well as of the specific characteristics of the cancer metabolic phenotype and the open questions in cancer research. NMR metabolomics in cancer research presents a detailed account of the NMR spectroscopy methods applied to metabolomics mixture analysis along with a discussion of their advantages and disadvantages. Following an overview of the potential use of NMR metabolomics

Outsourcing Biopharma R&D to India

Outsourcing Biopharma R&D to India
  • Author : P R Chowdhury
  • Publisher : Elsevier
  • Release : 05 May 2011
GET THIS BOOKOutsourcing Biopharma R&D to India

The trend of outsourcing to India for research and development is catching on fast. Over the last decade, worldwide pharmaceutical and biotechnology companies have made India their choice for a research destination. Initially R&D was inclined more towards developing products for the Indian market within the country. This led to several multinational companies opening up production plants in India, primarily due to the globalization of the Indian economy and offshoring jobs to India. Alongside, several global pharma-biotech majors ascertained

Bioinformatics for Biomedical Science and Clinical Applications

Bioinformatics for Biomedical Science and Clinical Applications
  • Author : K-H Liang
  • Publisher : Elsevier
  • Release : 31 July 2013
GET THIS BOOKBioinformatics for Biomedical Science and Clinical Applications

Contemporary biomedical and clinical research is undergoing constant development thanks to the rapid advancement of various high throughput technologies at the DNA, RNA and protein levels. These technologies can generate vast amounts of raw data, making bioinformatics methodologies essential in their use for basic biomedical and clinical applications. Bioinformatics for biomedical science and clinical applications demonstrates what these cutting-edge technologies can do and examines how to design an appropriate study, including how to deal with data and address specific clinical

The Funding of Biopharmaceutical Research and Development

The Funding of Biopharmaceutical Research and Development
  • Author : David R Williams
  • Publisher : Elsevier
  • Release : 31 October 2013
GET THIS BOOKThe Funding of Biopharmaceutical Research and Development

The funding of biopharmaceutical research and development provides a comprehensive critical review of the funding of research and development (R&D) in the human biopharmaceutical market sector. It addresses both private and public funding sources available in the US and internationally. The biopharmaceutical market is among the most research-intensive market sectors globally. Clinical researchers face a multitude of public and private funding options with respect to bringing their idea or innovation to market. These funding options are continually changing and

Concepts and Techniques in Genomics and Proteomics

Concepts and Techniques in Genomics and Proteomics
  • Author : N Saraswathy,P Ramalingam
  • Publisher : Elsevier
  • Release : 01 July 2011
GET THIS BOOKConcepts and Techniques in Genomics and Proteomics

Concepts and techniques in genomics and proteomics covers the important concepts of high-throughput modern techniques used in the genomics and proteomics field. Each technique is explained with its underlying concepts, and simple line diagrams and flow charts are included to aid understanding and memory. A summary of key points precedes each chapter within the book, followed by detailed description in the subsections. Each subsection concludes with suggested relevant original references. Provides definitions for key concepts Case studies are included to

Matlab® in Bioscience and Biotechnology

Matlab® in Bioscience and Biotechnology
  • Author : Leonid Burstein
  • Publisher : Elsevier
  • Release : 05 June 2011
GET THIS BOOKMatlab® in Bioscience and Biotechnology

MATLAB® in bioscience and biotechnology presents an introductory Matlab course oriented towards various collaborative areas of biotechnology and bioscience. It concentrates on Matlab fundamentals and gives examples of its application to a wide range of current bioengineering problems in computational biology, molecular biology, bio-kinetics, biomedicine, bioinformatics, and biotechnology. In the last decade Matlab has been presented to students as the first computer program they learn. Consequently, many non-programmer students, engineers and scientists have come to regard it as user-friendly and

Transporters in Drug Discovery and Development

Transporters in Drug Discovery and Development
  • Author : Yurong Lai
  • Publisher : Woodhead Publishing
  • Release : 22 August 2014
GET THIS BOOKTransporters in Drug Discovery and Development

Written by a leading researcher in the field, Transporters in Drug Discovery and Development provides a comprehensive and practical guide to drug transporter families that are the most important for drug discovery and development. It covers: an overview of transporter families and organ distribution; clinical relevant drug-drug interaction; clinical relevant polymorphism; drug transporter related pharmacokinetic, pharmacodynamics and toxicity; in vitro/in vivo probes of drug transport studies; the practical methodologies of industrial transporter screening and translational aspect in drug discovery

Lean Biomanufacturing

Lean Biomanufacturing
  • Author : Nigel J Smart
  • Publisher : Elsevier
  • Release : 31 October 2013
GET THIS BOOKLean Biomanufacturing

With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean

Allergens and Respiratory Pollutants

Allergens and Respiratory Pollutants
  • Author : Marc A. Williams
  • Publisher : Elsevier
  • Release : 18 July 2011
GET THIS BOOKAllergens and Respiratory Pollutants

Allergens and respiratory pollutants is a collection of 12 authoritative papers that draws upon the collective expertise of world leaders in the fields of innate immunity, immunotoxicology and pulmonary biology. The book critically explores the biological and immunological mechanisms that contribute to immune dysfunction on exposure to allergens and the susceptibility to infectious disease on exposure to ambient pollutants. The clinical relevance of exposure to ambient airborne xenobiotics is critically discussed and collectively, this book provides an educational forum that links

Computer-Aided Applications in Pharmaceutical Technology

Computer-Aided Applications in Pharmaceutical Technology
  • Author : Jelena Djuris
  • Publisher : Elsevier
  • Release : 10 April 2013
GET THIS BOOKComputer-Aided Applications in Pharmaceutical Technology

Research and development in the pharmaceutical industry is a time-consuming and expensive process, making it difficult for newly developed drugs to be formulated into commercially available products. Both formulation and process development can be optimized by means of statistically organized experiments, artificial intelligence and other computational methods. Simultaneous development and investigation of pharmaceutical products and processes enables application of quality by design concept that is being promoted by the regulatory authorities worldwide. Computer-aided applications in pharmaceutical technology covers the fundamentals

Ocular Transporters and Receptors

Ocular Transporters and Receptors
  • Author : Ashim K Mitra
  • Publisher : Elsevier
  • Release : 31 October 2013
GET THIS BOOKOcular Transporters and Receptors

Ocular transporters and receptors contains detailed descriptions of major transporters and receptors expressed in the eye, with special emphasis on their role in drug delivery. The complex anatomy and the existence of multiple barriers in the eye pose a considerable challenge to successful drug delivery to the eye. Hence ocular transporters and receptors are important targets for drug delivery. A significant advancement has been made in the field of ocular transport research and their role in drug delivery. In this

Therapeutic Protein Drug Products

Therapeutic Protein Drug Products
  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Release : 02 January 2012
GET THIS BOOKTherapeutic Protein Drug Products

Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches.