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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 ...
Downloadable data files. 11. FAERS FDA Adverse Event Reporting System (FAERS) Public Dashboard 12. Inactive Ingredient Search for Approved Drug Products Search 13. Medication Guides Search. 14. National Drug Code Directory Search. 15. Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) Search 16. OMUF OTC Monographs ...
Airtable – a spreadsheet-database hybrid, with the features of a database but applied to a spreadsheet. Coda; EditGrid – access, collaborate and share spreadsheets online, with API support; discontinued since 2014; Google Sheets – as part of Google Workspace; iRows – closed since 31 December 2006; JotSpot Tracker – acquired by Google Inc.
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In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Templates relating to drugs by Anatomical Therapeutic Chemical Classification System. The pages listed in this category are templates . This page is part of Wikipedia's administration and not part of the encyclopedia.
Template parameters [Edit template data] This template has custom formatting. Parameter Description Type Status; Drug name: drug_name: Name of the drug, medication, or vaccine, including combination drugs. The article title will be used if this is left blank. String: suggested: type: type
Version 3.0 also included drug transporter data, drug pathway data, drug pricing, patent and manufacturing data as well as data on >5000 experimental drugs. Version 4.0 was released in 2014. [ 4 ] This version included 1558 FDA-approved small molecule drugs, 155 biotech drugs and 4200 unique drug targets.