An OTC monograph is a “rule book” for each therapeutic category establishing conditions, such as active ingredients , uses (indications), doses, labeling, and testing, under which an OTC drug is generally recognized as safe and effective (GRASE) and can be marketed without a New Drug Application and FDA pre-market ...
What is the antibiotic monograph used for?
A drug monograph is a predetermined checklist covering active ingredients, doses, formulations and product labeling that the agency considers generally safe and effective for self use .
What is general monograph used for?
These general monographs give requirements that are applicable to all products in the given class or , in some cases, to any product in the given class for which there is a specific monograph in the Pharmacopoeia (see 1. General Notices, General monographs).
What is a drug product monograph?
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 drug monograph is important?
It is the most comprehensive source for medicine quality standards in the world. ... 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 contains?
A publication that specifies for a drug (or class of related drugs) the kinds and amounts of ingredients it may contain, the conditions and limitations for which it may be offered, directions for use, warnings, and other information that its labeling must contain.
What are the side effects of monograph?
Adverse effects: Nausea, diarrhea, abdominal pain, CNS (dizziness, headache), rash, gynecomastia .
How long is a monograph?
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.
How is a drug monograph approved?
Industry-Initiated Order
If FDA accepts the OMOR for filing, FDA will the review the OMOR and issue a proposed order . The public will receive at least 45 calendar days to submit comments on the proposed order. After reviewing and considering the comments, FDA will issue a final order which is the final OTC monograph.
Is doxycycline a powerful antibiotic?
Doxycycline is an antibiotic drug that kills a wide, weird and wonderful range of bugs that are often difficult to treat with other antibiotics. These include bacteria and parasites that take up residence inside our cells (called “intracellular organisms”), making them hard for most antibiotics to reach.
What is the fastest growing drug in the United States?
Prescription drug abuse continues to be the nation’s fastest growing drug problem, according to a new report by the Drug Enforcement Administration (DEA). Americans are abusing prescription drugs at a higher prevalence rate than any illicit drug except marijuana.
How do you cite a product monograph?
- Elements within the reference entry: Author. (Date). Title. ...
- Here is an example from a printed insert: Shionogi Pharma. (2010). Ulesfia Lotion: Highlights of prescribing information. ...
- Here is an example from a website: Shionogi Pharma. (2010). ...
- In-text citation for both reference entries: (Shionogi Pharma, 2010)
What is a general monograph?
These general monographs give requirements that are applicable to all products in the given class or, in some cases, to any product in the given class for which there is a specific monograph in the Pharmacopoeia (see 1. General Notices, General monographs).
What is the difference between monograph and pharmacopoeia?
In a broader sense, pharmacopoeia is a reference work for pharmaceutical drug specifications . Descriptions of preparations are called monographs. A monograph is a paper on a single topic. ... The pharmacopoeia contains specific monographs governing the quality of specific herbal products.
How do you do a monograph?
- A Statement of the Problem. The problem or area that the monograph will address is ... ...
- A Brief Review of the Literature. Persons who have already talked and/or written about my topic include... . ...
- Proposed Research Methods. ...
- Results, Discussion and Implications.
What is a monograph thesis?
A monograph is a unified text describing a specialist topic in detail written by a single author . A doctoral thesis written as a monograph is structured in various chapters with an introduction and a conclusion, and the PhD-candidate is the sole author.
