monograph

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  • noun

Words related to monograph

a detailed and documented treatise on a particular subject

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Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease.
It is divided into two parts; Part 1 is the A-Z Drug Monographs with clearly labelled alphabetical thumb tabs and coding to denote high alert drugs and Part 2 is the Drug Classification Tables, a resource which allows comparison within the different groups.
For example, American Society of Health-System Pharmacists Essentials and Lexidrugs are created by separate publishers but provide similar brief drug monographs, and there are two intravenous-drug interactions tools from two publishers.
Once the OTC drug is eligible for the OTC drug monograph system, the sponsor submits safety and effectiveness data for evaluation to the FDA, which includes the official or proposed USP-NF monograph.
Each drug monograph includes: generic name, pronunciation, common brand names, drug class, controlled substances schedule, action, uses, doses and routes of administration, side effects and adverse reactions, contraindications, drug interactions of concern to oral health care and other such considerations.
The remaining Portion of the screen provides the USP drug monograph information.
Each of the 5 drug information resources had the opportunity to present package insert biomarker information in the drug monograph for each of the 65 drugs, for a total of 325 opportunities.
While it is true that triclosan was invented in the mid-1960s, the US Food and Drug Administration (FDA) did not issue its first proposed over-the-counter (OTC) drug monograph allowing for the ingredient to be used and marketed in antimicrobial washes until 1978," said DeLeo.
Lexi-CALC is built on Lexi-Comp's user-friendly interfaces, directly linking each dosing field under a drug monograph to the appropriate calculator.
In addition, access to each drug monograph needs to be simpler and quicker, like the access to drugs in the PDR section.
For example, when a search for a drug name leads to a drug monograph, it is not immediately clear whether the result describes therapeutic uses of the drug or contraindications.
Each drug monograph is divided into fairly standard but discontinuous sections that are accessed using icons in the right margin.
OTC Drug Monograph is also analyzed in-depth in this research report.
Each drug monograph provides information on the method of preparation and administration via the IV, IM, and SC routes, plus advice on risk reduction and safety, guidelines on monitoring for complications and adverse reactions, and data on Y-site and syringe driver compatibility.
In 1972, the FDA created the OTC drug monograph system as a means to protect the public by examining all the OTC drugs in the marketplace to establish whether they are safe and effective.