Oct 19, 2023 19:48
9 mos ago
41 viewers *
English term
Argentina
Pre-NDA
English to Spanish
Medical
Medical (general)
Medical
Hello,
What is the equivalent of "Pre-NDA" in the following sentence:
"At the time of writing this report, XX had been approved for emergency use in China on December 2, 2022, and a Pre-NDA had been submitted on August 18, 2023."
Thanks!
What is the equivalent of "Pre-NDA" in the following sentence:
"At the time of writing this report, XX had been approved for emergency use in China on December 2, 2022, and a Pre-NDA had been submitted on August 18, 2023."
Thanks!
Proposed translations
(Spanish)
| 3 +3 | Pre solicitud de autorización de registro |
Laura Mico
|
| 5 | Preacuerdo de confidencialidad |
Rubén Méndez Suárez
|
Proposed translations
+3
7 mins
Laura Mico
Spain
Spain
Native in Spanish
Specializes in field
Spain
Medicine & Marketing Chartered Linguist
Native in: Spanish (Variants: Standard-Spain, US, Latin American) 
Works in: English to Spanish, Spanish to English, Spanish
Related KudoZ points
:
12
Selected
Pre solicitud de autorización de registro
I think NDA refers to "new drug applications".
Su nombre oficial en España es solicitud de autorización de una especialidad farmacéutica, pero se utiliza también mucho la forma abreviada solicitud de registro.
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Note added at 9 minutos (2023-10-19 19:58:22 GMT)
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Examples in https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1038/clpt.2...
https://link.springer.com/article/10.1177/009286159803200324
NDA: Libro Rojo
Su nombre oficial en España es solicitud de autorización de una especialidad farmacéutica, pero se utiliza también mucho la forma abreviada solicitud de registro.
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Note added at 9 minutos (2023-10-19 19:58:22 GMT)
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Examples in https://ascpt.onlinelibrary.wiley.com/doi/abs/10.1038/clpt.2...
https://link.springer.com/article/10.1177/009286159803200324
NDA: Libro Rojo
4 KudoZ points awarded for this answer.
Comment: "Thanks!"
3 mins
Rubén Méndez Suárez
Spain
Spain
Native in Spanish
Spain
IT and Localisation Expert
Native in: Spanish (Variant: Standard-Spain)
Works in: English to Spanish, Spanish, Portuguese to Spanish, and 1 more.
Related KudoZ points
:
8
Preacuerdo de confidencialidad
Just as is.
Peer comment(s):
| neutral |
abe(L)solano
: aquí no es non-disclosure agreement. Hablan de la autorización de uso
20 hrs
|
Reference comments
9 mins
Reference:
see
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9628473/
and other public sources. Basic and regulatory characteristics were extracted and manually verified, including therapeutic class, dates of receipt of new drug application (NDA) and date of the first approval in China, number of review cycles, qualification of expedited programs such as priority review, and manufacturing site of the drug [manufactured in China (domestic) or outside China (imported)]. When a drug has multiple approved indications, the approval date of the first indication was used.
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Note added at 11 minutos (2023-10-19 20:00:28 GMT)
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solicitud de autorización de comercialización de un nuevo fármaco
and other public sources. Basic and regulatory characteristics were extracted and manually verified, including therapeutic class, dates of receipt of new drug application (NDA) and date of the first approval in China, number of review cycles, qualification of expedited programs such as priority review, and manufacturing site of the drug [manufactured in China (domestic) or outside China (imported)]. When a drug has multiple approved indications, the approval date of the first indication was used.
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Note added at 11 minutos (2023-10-19 20:00:28 GMT)
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solicitud de autorización de comercialización de un nuevo fármaco
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