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 are the side effects of monograph?
Adverse effects:
Nausea, diarrhea, abdominal pain, CNS (dizziness, headache), rash, gynecomastia
.
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).
Why are drug monographs important?
The GPhP guidance continues, “Pharmacopoeial monographs
provide an important tool for assurance of the quality of marketed pharmaceutical ingredients and products through testing of their quality
.” These monographs are generally available for excipients, drug substances, and drug products, providing the tests, …
What are the components of a drug monograph?
Drug monograph:
A written, unbi- ased evaluation of a specific medica- tion. 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.
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 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.
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 use for Benzonatate?
Benzonatate is used to
relieve coughing
. Benzonatate is a non-narcotic cough medicine that numbs the throat and lungs, making the cough reflex less active. Benzonatate may also be used for purposes not listed in this medication guide.
What is a monograph in 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.
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.
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.
What is difference between USP and NF?
USP–NF is a combination of
two compendia, the United States Pharmacopeia (USP) and the National Formulary (NF)
. … Excipient monographs are in the NF. However, if an excipient is also used as a pharmaceutical active in an FDA-approved product released in the US, its monograph will appear in the USP section instead.
What is monograph in IP?
IP is a compilation of official standards for drugs manufactured and/or marketed in India. A monograph states
the quality or test parameters, the acceptance criteria and details of the tests that are to be performed to determine compliance with the criteria
.
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).
Why are monographs important to pharmaceutical scientists?
Monographs
provide basic pharmacokinetic information about each drug, some metabolic information and some review of literature on the compound
. Arnold, London (Oxford University Press, U.S.) This text provides a solid overview of the pharmacology of many drugs of abuse.
