Glossary entry (derived from question below)
português term or phrase:
monografia farmacopeica
inglês translation:
pharmacopeial monograph
Added to glossary by
Lilian Magalhães
Dec 7, 2016 11:31
7 yrs ago
10 viewers *
português term
Brasil
Experienced and reliable translator
Native in: português 
Works in: inglês para português, espanhol para português, português para inglês
monografia farmacopeica
português para inglês
Medicina
Medicina: farmacêutica
anvisa
Não é permitida a adoção mista ou incompleta de monografias farmacopeicas para um ativo, excipiente ou produto acabado. Portanto, uma vez que uma farmacopeia é utilizada como referência para o controle de qualidade de um princípio ativo, excipiente ou produto acabado, todos os testes preconizados neste compêndio devem ser realizados.
Contudo, uma vez adotada uma farmacopeia reconhecida pela Agência na íntegra, é permitida a complementação de um ou mais testes, utilizando outra farmacopeia.
Contudo, uma vez adotada uma farmacopeia reconhecida pela Agência na íntegra, é permitida a complementação de um ou mais testes, utilizando outra farmacopeia.
Proposed translations
(inglês)
| 4 +2 | pharmacopeial monograph |
Gilmar Fernandes
|
| 4 +1 | pharmacopoeial monographs |
Bruno Michel (X)
|
Change log
Dec 12, 2016 00:40: Matheus Chaud changed "Field" from "Outra" to "Medicina"
Proposed translations
+2
13 minutos
Gilmar Fernandes
Estados Unidos
Estados Unidos
Native in português
&
inglês
Estados Unidos
25 + yrs. Business experience PORT- ENG
Native in: português , inglês
Works in: português para inglês, inglês para português
Related KudoZ points
:
54
Selected
pharmacopeial monograph
https://www.google.com.br/search?q="pharmocopeic monograph"&...
https://en.wikipedia.org/wiki/Monograph
In United States Food and Drug Administration regulation
See also: Pharmacopoeia
In the context of Food and Drug Administration (FDA) regulation, monographs represent published standards by which the use of one or more substances is automatically authorized. For example, the following is an excerpt from the Federal Register: "The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products."[6] Such usage has given rise to the use of the word monograph as a verb, as in "this substance has been monographed by the FDA".
https://en.wikipedia.org/wiki/Monograph
In United States Food and Drug Administration regulation
See also: Pharmacopoeia
In the context of Food and Drug Administration (FDA) regulation, monographs represent published standards by which the use of one or more substances is automatically authorized. For example, the following is an excerpt from the Federal Register: "The Food and Drug Administration (FDA) is issuing a final rule in the form of a final monograph establishing conditions under which over-the-counter (OTC) sunscreen drug products are generally recognized as safe and effective and not misbranded as part of FDA's ongoing review of OTC drug products."[6] Such usage has given rise to the use of the word monograph as a verb, as in "this substance has been monographed by the FDA".
4 KudoZ points awarded for this answer.
Comment: "grata, mestre"
+1
13 minutos
pharmacopoeial monographs
http://www.usp.org/usp-nf/harmonization
https://en.wikipedia.org/wiki/Pharmacopoeia
https://scholar.google.com.br/scholar?q=pharmacopoeial monog...
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Note added at 20 mins (2016-12-07 11:52:18 GMT)
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USP Harmonized Pharmacopeial Monographs
PDG Purpose
The purpose of PDG is to harmonize pharmacopeial standards (excipient monographs and selected general chapters) in three major regions of the world. Harmonization reduces manufacturers' burden of having to perform analytical procedures in different ways, using different acceptance criteria, in order to satisfy pharmacopeial requirements that vary across regions. At all times, PDG strives to maintain a consistent level of science across the three pharmacopoeias, with the shared goal of protecting the public health. A pharmacopeial monograph for an active ingredient or excipient, preparation, or other substance used in the manufacture or compounding of a medicinal product generally provides a specification by way of a name, definition, description, tests, procedures, and acceptance criteria and sometimes packaging, labeling, and storage statements. For frequently cited procedures, or for broad-based guidance, a monograph may reference a general chapter.
http://www.usp.org/usp-nf/harmonization
https://en.wikipedia.org/wiki/Pharmacopoeia
https://scholar.google.com.br/scholar?q=pharmacopoeial monog...
--------------------------------------------------
Note added at 20 mins (2016-12-07 11:52:18 GMT)
--------------------------------------------------
USP Harmonized Pharmacopeial Monographs
PDG Purpose
The purpose of PDG is to harmonize pharmacopeial standards (excipient monographs and selected general chapters) in three major regions of the world. Harmonization reduces manufacturers' burden of having to perform analytical procedures in different ways, using different acceptance criteria, in order to satisfy pharmacopeial requirements that vary across regions. At all times, PDG strives to maintain a consistent level of science across the three pharmacopoeias, with the shared goal of protecting the public health. A pharmacopeial monograph for an active ingredient or excipient, preparation, or other substance used in the manufacture or compounding of a medicinal product generally provides a specification by way of a name, definition, description, tests, procedures, and acceptance criteria and sometimes packaging, labeling, and storage statements. For frequently cited procedures, or for broad-based guidance, a monograph may reference a general chapter.
http://www.usp.org/usp-nf/harmonization
Reference comments
58 minutos
Reference:
see
How are Pharmacopoeial monographs written, interpreted and ...
https://www.raci.org.au/document/item/2056
Overview. • How to read and interpret monographs. – The format and style of monographs. – How to interpret. • When you have a different impurity profiles.
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Note added at 1 hr (2016-12-07 12:33:43 GMT)
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Pharmacopeial
319,000 result
Pharmacopoeial
189,000
much will depend on the target country
https://www.raci.org.au/document/item/2056
Overview. • How to read and interpret monographs. – The format and style of monographs. – How to interpret. • When you have a different impurity profiles.
--------------------------------------------------
Note added at 1 hr (2016-12-07 12:33:43 GMT)
--------------------------------------------------
Pharmacopeial
319,000 result
Pharmacopoeial
189,000
much will depend on the target country
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