Search results
Results from the WOW.Com Content Network
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 ...
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.
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
The Standard for Exchange of Nonclinical Data (SEND) is an implementation of the CDISC Standard Data Tabulation Model (SDTM) for nonclinical studies, which specifies a way to present nonclinical data in a consistent format. These types of studies are related to animal testing conducted during drug development.
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.
To legally test the drug on human subjects in the United States, the maker must first obtain an Investigational New Drug (IND) designation from FDA. [5] This application is based on nonclinical data, typically from a combination of in vivo and in vitro laboratory safety studies, that shows the drug is safe enough to test in humans. [5]
The template does not at the current time include summary information about the drug class itself. Instead, it contains a consistent interface to other sources that provide information about the drug class. Don't worry about trying to fill in all the fields – even if you can only get one or two, that still can be useful.