What does a product monograph contain?

What does a product monograph contain?

A Product Monograph is a factual, scientific document on a drug product that, devoid of promotional material, describes the properties, claims, indications and conditions of use of the drug and contains any other information that may be required for optimal, safe and effective use of the drug.

Why would we need to read a product monograph?

From a medical and scientific standpoint, the prime objective of a product monograph is to provide essential information that may be required for the safe and effective use of a new drug.

How do you do a drug monograph?

Each written monograph must be typed (using a font size of 11 or higher) and must include the drug’s name (generic and at least one U.S. trade name), your name, and the drug’s chemical structure at the top of the monograph (see example in the next chapter).

What are the components of a drug monograph?

Drug monograph: This document includes the drug name, therapeutic class, pharmacology, indications for use, summary of clinical trials, pharmacokinetics/dynamics, ad- verse effects, drug interactions, dosage regimens, and cost.

What is the USP standard?

A USP Reference Standard (also known as a physical standard) is a known quantity of a drug substance or ingredient, developed in alignment with the specifications outlined in the USP–NF.

What is a USP-NF monograph?

USP-NF includes three types of quality standards for prescription medicines: Monographs articulate the quality expectations for a medicine including for its identity, strength, purity, and performance. They also describe the tests to validate that a medicine and its ingredients meet these criteria.

What does a monograph look like?

A Monograph has some common characteristics with books and review (survey) papers. A monograph is a special type of book written on a single specialized topic, devoted mainly for research works; could pose some unsolved problems and may provide detained explanation of some research papers.

What is a monograph document?

A monograph is a specialist work of writing (in contrast to reference works) or exhibition on a single subject or an aspect of a subject, often by a single author or artist, and usually on a scholarly subject.

How many words should a monograph contain?

The longer option, monographs, which typically are around 70,000 to 100,00 words in length, are more often used in humanities and social sciences where research is based on text-based discussions more than laboratory results.