Statement of benefit-risk ratio assesment for substantiality

Spanish translation: declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones

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
Entered by: Neil Ashby

14:56 Oct 5, 2020
English to Spanish translations [PRO]
Medical - Medical: Pharmaceuticals / Update of Invetigator Brochure
English term or phrase: Statement of benefit-risk ratio assesment for substantiality
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!
Belén Nieto
Local time: 16:10
declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones
Explanation:
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.

--------------------------------------------------
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...
Selected response from:

Neil Ashby
Spain
Local time: 20:10
Grading comment
Thanks a lot Neil!
4 KudoZ points were awarded for this answer



Summary of answers provided
1 +4declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones
Neil Ashby
3Informe de evaluación comparativa de la relación riesgo-beneficio
Mónica Algazi


  

Answers


11 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
Informe de evaluación comparativa de la relación riesgo-beneficio


Explanation:
Lo expresaría así en función del contexto.

Mónica Algazi
Uruguay
Local time: 16:10
Native speaker of: Native in SpanishSpanish
PRO pts in category: 202
Login to enter a peer comment (or grade)

41 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5 peer agreement (net): +4
statement of benefit-risk ratio assesment for substantiality
declaración de la evaluación de la relación riesgo-beneficio para respaldar las reivindicaciones


Explanation:
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.

--------------------------------------------------
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...

Neil Ashby
Spain
Local time: 20:10
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 229
Grading comment
Thanks a lot Neil!
Notes to answerer
Asker: Hello Neil, it is a prescription drug for Arthritis. Thanks a lot for your answer!


Peer comments on this answer (and responses from the answerer)
agree  EirTranslations
3 mins
  -> Thanks Eir, appreciate it.

agree  Chema Nieto Castañón: El limitado contexto no ayuda mucho, pero pej. Informe de evaluación riesgo-beneficio como justificación (¿clínica? ¿para investigación en humanos? ¿de propiedades (médicas) del fármaco?)
1 day 3 hrs
  -> Thanks Chema, saludos.

agree  Leda Roche
1 day 8 hrs
  -> Thanks again Leda

agree  Antonella Perazzoni
2 days 3 hrs
  -> Thanks again Antonella
Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.


See also:

Your current localization setting

English

Select a language

Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search