Aug 5 08:52
1 mo ago
22 viewers *
English term
biologic-led combination products
English to Russian
Medical
Medical: Pharmaceuticals
из руководства FDA
Proposed translations
(Russian)
| 4 +1 | * |
hawkwind
|
| 4 | См. ниже |
Alieksei Seniukovich
|
| 4 | комбинированные биологические лекарственные препараты |
cherepanov
|
References
| Combination products |
Igor Andreev
|
Proposed translations
3 mins
Alieksei Seniukovich
Poland
Poland
Native in Russian
Specializes in field
Poland
'Medical Linguistics Professional'
Native in: Russian (Variant: Standard-Russia) 
Works in: English to Russian, Russian to English, English to Belarusian, and 3 more.
Related KudoZ points
:
857
См. ниже
Перевод: комбинированные препараты, в которых основным действующим веществом является биологическое действующее вещество
Думаю, что смысл примерно такой. Дальше можно пробовать разные формулировки.
Думаю, что смысл примерно такой. Дальше можно пробовать разные формулировки.
23 mins
cherepanov
Ukraine
Ukraine
Native in Russian
Specializes in field
Ukraine
20 years in translations, Ph.D. (Chem)
Native in: Russian
Works in: English to Russian, English to Ukrainian
Related KudoZ points
:
1170
комбинированные биологические лекарственные препараты
Так их называют здесь в аналитической статье:
https://cyberleninka.ru/article/n/podhody-k-klinicheskoy-raz...
Подходы к клинической разработке комбинированных лекарственных препаратов
в Российской Федерации и Евразийском экономическом союзе с учетом требований
действующего законодательства
...Аналогичные требования предъявляются к пред-
регистрационному клиническому изучению рефе-
рентных комбинированных биологических лекар-
ственных препаратов.
Чтобы увидеть эту цитату, нужно нажать не на кнопку ЧИТАТЬ, а на одну кнопку левее со стрелкой загрузки.
Можно вместо "биологические" выбрать вариант "биологического происхождения", как здесь:
https://gxpnews.net/terminologiya/immunobiologicheskie-lekar...
... Иммунобиологические лекарственные препараты — лекарственные препараты биологического происхождения, предназначенные для...
https://cyberleninka.ru/article/n/podhody-k-klinicheskoy-raz...
Подходы к клинической разработке комбинированных лекарственных препаратов
в Российской Федерации и Евразийском экономическом союзе с учетом требований
действующего законодательства
...Аналогичные требования предъявляются к пред-
регистрационному клиническому изучению рефе-
рентных комбинированных биологических лекар-
ственных препаратов.
Чтобы увидеть эту цитату, нужно нажать не на кнопку ЧИТАТЬ, а на одну кнопку левее со стрелкой загрузки.
Можно вместо "биологические" выбрать вариант "биологического происхождения", как здесь:
https://gxpnews.net/terminologiya/immunobiologicheskie-lekar...
... Иммунобиологические лекарственные препараты — лекарственные препараты биологического происхождения, предназначенные для...
+1
1 day 5 hrs
*
комбинированные изделия (продукты), основной механизм действия которых обеспечивается биологическим продуктом (препаратом)
https://www.fda.gov/media/119958/download
This pathway is generally appropriate for biologic-led combination products
...
For example, this pathway would be appropriate for the following products:
• a gene therapy combined with a specialized delivery catheter
• a vaccine in a pre-filled syringe
• a protein product in an autoinjector
https://www.federalregister.gov/documents/2004/05/07/04-1044...
Mode of action
would be defined as “the means by which a product achieves a therapeutic effect.” For purposes of this definition, “therapeutic” effect or action includes any effect or action of the combination product intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body. Products may have a drug, biological product, or device mode of action.
Primary mode of action
would be defined as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.” This would be the mode of action that is expected to make the greatest contribution to the overall therapeutic effects of the combination product. As with “mode of action,” for purposes of PMOA, “therapeutic” effect or action includes any effect or action of the combination product intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body.
https://www.laboratuar.com/ru/testler/medikal-cihaz-testleri...
основной механизм действия изделия
--------------------------------------------------
Note added at 1 day 5 hrs (2024-08-06 14:41:08 GMT)
--------------------------------------------------
https://seed.nih.gov/sites/default/files/2024-04/Regulatory-...
2.2.a Biologic-Led Combination Products
If the biologic is the PMOA, then CBER is the lead review center for the combination product, under
one of the two BLA pathways under the Public Health Service Act.
https://www.fda.gov/media/119958/download
This pathway is generally appropriate for biologic-led combination products
...
For example, this pathway would be appropriate for the following products:
• a gene therapy combined with a specialized delivery catheter
• a vaccine in a pre-filled syringe
• a protein product in an autoinjector
https://www.federalregister.gov/documents/2004/05/07/04-1044...
Mode of action
would be defined as “the means by which a product achieves a therapeutic effect.” For purposes of this definition, “therapeutic” effect or action includes any effect or action of the combination product intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body. Products may have a drug, biological product, or device mode of action.
Primary mode of action
would be defined as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.” This would be the mode of action that is expected to make the greatest contribution to the overall therapeutic effects of the combination product. As with “mode of action,” for purposes of PMOA, “therapeutic” effect or action includes any effect or action of the combination product intended to diagnose, cure, mitigate, treat, or prevent disease, or affect the structure or any function of the body.
https://www.laboratuar.com/ru/testler/medikal-cihaz-testleri...
основной механизм действия изделия
--------------------------------------------------
Note added at 1 day 5 hrs (2024-08-06 14:41:08 GMT)
--------------------------------------------------
https://seed.nih.gov/sites/default/files/2024-04/Regulatory-...
2.2.a Biologic-Led Combination Products
If the biologic is the PMOA, then CBER is the lead review center for the combination product, under
one of the two BLA pathways under the Public Health Service Act.
Peer comment(s):
| agree |
Igor Andreev
: С учетом определения combination products, которое предполагает наличие device в их составе, наряду с drug and biologic также остановился бы на продуктах, но не препаратах
22 hrs
|
|
Спасибо!
|
Reference comments
2 days 3 hrs
Igor Andreev
Native in Russian
Native in: Russian 
Works in: English to Russian, Ukrainian to Russian, English to Ukrainian
Related KudoZ points
:
625
Reference:
Combination products
What is a combination product?
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include:
1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity [often referred to as a “single-entity” combination product];
2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products [often referred to as a “co-packaged” combination product];
3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose) [often referred to as a “cross-labeled” combination product]; or
4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect [another type of “cross-labeled” combination product].
https://www.fda.gov/combination-products/about-combination-p...
A combination product is a product composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product. Under 21 CFR 3.2 (e), a combination product is defined to include:
1. A product comprised of two or more regulated components (i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic) that are physically, chemically, or otherwise combined or mixed and produced as a single entity [often referred to as a “single-entity” combination product];
2. Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products [often referred to as a “co-packaged” combination product];
3. A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where, upon approval of the proposed product, the labeling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose) [often referred to as a “cross-labeled” combination product]; or
4. Any investigational drug, device, or biological product packaged separately that according to its proposed labeling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect [another type of “cross-labeled” combination product].
https://www.fda.gov/combination-products/about-combination-p...
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