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  • Subjects - XML (eXtensible Markup Language): An Overview

    As web developers know all too well, basic HTML (HyperText Markup Language) doesn't provide any structure to Web pages, and the formatting is mixed with the content. To
    According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
    allow Web pages to be structured for automated processing (e.g. electronic commerce), the World Wide Web Consortium (W3C) developed an enhancement to HTML. The result
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    were two new languages; one was XSL (eXtensible Style Language), and the other was XML (eXtensible Markup Language), a system for defining, validating, and shari
    lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

    g document formats on the Web.

    XML is best known to many bloggers and Netizens as RSS (Rich Site Summary/Really Simple Syndication), which is actually a lightweight XM
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    L format used to share headlines and blog feeds.

    History

    The W3C, an organization devoted to developing the Web and standardizing protocols, formed an XML Work
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    ng Group chaired by Jon Bosak of Sun Microsystems in 1996. Several key industry players who were also included in the working group were Adobe, Hewlett-Packard, Microso
    ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
    ft, Netscape, and Fuji Xerox.

    The group published a working draft for XML in November of the same year. Two years later, the W3C announced the release of the XML 1.0 s
    easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
    pecification.

    The year 1999 found the release of two W3C Recommendations on XML. The first was entitled Namespaces on XML, and the other was Associating Styl
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    sheets with XML documents. In January of 2001, the Internet Engineering Task Force (IETF) released a Proposed Standard on XML Media Types.

    Profile

    X
    and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
    ML is an open, human-readable text format derived from the Standard Generalized Markup Language (SGML). Originally meant for large-scale electronic publishing, XML is n
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    w being used in the exchange of various types of data on the Web and elsewhere. It is also becoming a language of choice for communication between application programs.
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a


    The XML Working Group’s design goals (taken from http://www.w3.org) for XML were:

      XML shall be straightforwardly usable over the Internet.
      XML shall
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    support a wide variety of applications.
      XML shall be compatible with SGML.
      It shall be easy to write programs that process XML documents.
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    > The number of optional features in XML is to be kept to the absolute minimum, ideally zero.
      XML documents should be human-legible and reasonably clear.
      tions increase the patient compliance?
      What would be the developing cost?
      How to tackle the risks encountered during combination product developmen
      >
        The XML design should be prepared quickly.
        The design of XML shall be formal and concise.
        XML documents shall be easy to create.
      t?

      As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
      Terseness in XML markup is of minimal importance.


    The markup language describes XML documents, which are a class of data objects. Moreover, XML also describes th
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    e behavior of software modules called XML processors. These are used to read XML documents and provide access to their content and structure.

    Syntax

    Those fami
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    liar enough with HTML will find XML syntax a lot similar. However, don't assume that coding in XML is painlessly easy -- XML is stricter than HTML, and sloppy HTML code
    .

    As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
    s will do well to remember that. Several reminders when coding in XML:

      All elements must have a closing tag.
      All elements must be properly nested.
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
      All tags are case sensitive.
      All attribute values must be enclosed in quotation marks.


    A good hands-on tutorial on XML can be found at W3Schools.com


    tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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