Glossary entry (derived from question below)
English term or phrase:
Statement of benefit-risk ratio assesment for substantiality
Spanish translation:
declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones
Added to glossary by
Neil Ashby
Oct 5, 2020 14:56
3 yrs ago
45 viewers *
English term
Statement of benefit-risk ratio assesment for substantiality
English to Spanish
Medical
Medical: Pharmaceuticals
Update of Invetigator Brochure
Hola a todos:
Tengo dudas con la palabra substantiality.
Es un breve texto sobre la actualización en el Manual del Investigador y ese es el título.
Statement of benefit-risk ratio assesment for substantiality
The new version of the Investigator’s Brochure has been evaluated for the below points:
The changes made to previous version dated XXX of the Investigator’s Brochure affect the risk/benefit ratio of the product.
YES NO X
There are changes to the reference safety information for assesing whether an Adverse reaction is a suspected unexpected serious adverse reaction (SUSAR).
YES X NO
Se refiere al nivel de importancia de los cambios?
Desde ya muchas gracias!
Tengo dudas con la palabra substantiality.
Es un breve texto sobre la actualización en el Manual del Investigador y ese es el título.
Statement of benefit-risk ratio assesment for substantiality
The new version of the Investigator’s Brochure has been evaluated for the below points:
The changes made to previous version dated XXX of the Investigator’s Brochure affect the risk/benefit ratio of the product.
YES NO X
There are changes to the reference safety information for assesing whether an Adverse reaction is a suspected unexpected serious adverse reaction (SUSAR).
YES X NO
Se refiere al nivel de importancia de los cambios?
Desde ya muchas gracias!
Change log
Oct 12, 2020 19:56: Neil Ashby Created KOG entry
Proposed translations
+4
41 mins
Neil Ashby
Spain
Spain
Native in English
Specializes in field
Spain
DrNeil TechTrans, Precision & Clarity
Native in: English
Works in: Spanish to English, English
Related KudoZ points
:
241
Selected
declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones
declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones
Could it be talking about substantiating product claims?
If it is a cosmetic product or a nonprescription "remedy", I think this could on the right lines.
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Note added at 50 mins (2020-10-05 15:46:37 GMT)
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Here's the FDA's definition:
Substantial Evidence (Substantiation)
Substantial evidence refers to the data needed to support claims about an advertised drug. Before the FDA approves a drug for marketing, drug companies must complete studies to show that the drug does what they say it does. These studies are also required to support advertising claims about the drug. Drug companies need to have at least two studies to support these claims.
https://www.fda.gov/drugs/prescription-drug-advertising/drug...
Cosmetics Claims Substantiation: What You Need to Know
The claims you put on your cosmetic product’s packaging must be substantiated. Even where cosmetics claims substantiation isn’t required by law, it’s a responsible business practice to put your cosmetic products through appropriate testing before they hit the market.
https://www.bioalternatives.com/en/cosmetics-claims-substant...
Four Basic Rules of Cosmetic Claim Substantiation
http://www.scientificspectator.com/documents/personal care s...
It also applies to medical devices and healthcare services/products:
For claims involving healthcare services or products, those claims must be substantiated by competent and reliable evidence.
https://cohenhealthcarelaw.com/fda-ftc-law/advertising-and-m...
Nutrients and foods:
It is important to consider whether or not the health claim proposed is based on the essentiality of nutrients. Data requirements for claims based on the essentiality of nutrients differ compared to other claims, e.g. for the characterisation of the food/constituent, for the characterisation of the claimed effect, for the scientific substantiation of the claim and for establishing conditions of use.
https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_a...
Could it be talking about substantiating product claims?
If it is a cosmetic product or a nonprescription "remedy", I think this could on the right lines.
--------------------------------------------------
Note added at 50 mins (2020-10-05 15:46:37 GMT)
--------------------------------------------------
Here's the FDA's definition:
Substantial Evidence (Substantiation)
Substantial evidence refers to the data needed to support claims about an advertised drug. Before the FDA approves a drug for marketing, drug companies must complete studies to show that the drug does what they say it does. These studies are also required to support advertising claims about the drug. Drug companies need to have at least two studies to support these claims.
https://www.fda.gov/drugs/prescription-drug-advertising/drug...
Cosmetics Claims Substantiation: What You Need to Know
The claims you put on your cosmetic product’s packaging must be substantiated. Even where cosmetics claims substantiation isn’t required by law, it’s a responsible business practice to put your cosmetic products through appropriate testing before they hit the market.
https://www.bioalternatives.com/en/cosmetics-claims-substant...
Four Basic Rules of Cosmetic Claim Substantiation
http://www.scientificspectator.com/documents/personal care s...
It also applies to medical devices and healthcare services/products:
For claims involving healthcare services or products, those claims must be substantiated by competent and reliable evidence.
https://cohenhealthcarelaw.com/fda-ftc-law/advertising-and-m...
Nutrients and foods:
It is important to consider whether or not the health claim proposed is based on the essentiality of nutrients. Data requirements for claims based on the essentiality of nutrients differ compared to other claims, e.g. for the characterisation of the food/constituent, for the characterisation of the claimed effect, for the scientific substantiation of the claim and for establishing conditions of use.
https://www.aesan.gob.es/AECOSAN/docs/documentos/seguridad_a...
Note from asker:
| Hello Neil, it is a prescription drug for Arthritis. Thanks a lot for your answer! |
4 KudoZ points awarded for this answer.
Comment: "Thanks a lot Neil!"
11 mins
Mónica Algazi
Uruguay
Uruguay
Native in Spanish
Uruguay
ATA-certified English-Spanish translator
Native in: Spanish (Variant: Latin American) 
Works in: English to Spanish
Related KudoZ points
:
218
Informe de evaluación comparativa de la relación riesgo-beneficio
Lo expresaría así en función del contexto.
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