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The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
Structured Product Labeling (SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of detailed information about the drug.
In drug development and medical device development [1] the Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product ("IP" or "study drug") obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new ...
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Interactive Forms is a mechanism to add forms to the PDF file format. PDF currently supports two different methods for integrating data and PDF forms. Both formats today coexist in the PDF specification: [38] [53] [54] [55] AcroForms (also known as Acrobat forms), introduced in the PDF 1.2 format specification and included in all later PDF ...
An electronic data capture (EDC) system is a computerized system designed for the collection of clinical data in electronic format for use mainly in human clinical trials. [1] EDC replaces the traditional paper-based data collection methodology to streamline data collection and expedite the time to market for drugs and medical devices.
An example of a résumé with a common format with the name John Doe. A résumé or resume (or alternatively resumé), [a] [1] is a document created and used by a person to present their background, skills, and accomplishments. Résumés can be used for a variety of reasons, but most often are used to secure new jobs, whether in the same ...
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