English to Portuguese translations [PRO]
Science - Science (general) / Production Batches | | English term or phrase: exhibit batches | | Contexto: "To perform stability studies for exhibit batches, as well as development batches". Sei que exhibit batch é um lote produzido para testes e não para comercialização. É o mesmo que lotes pilotos? Ou há outro termo para esse tipo de lote em português? Muito obrigada. |
| Juliana RalaKudoZ activityQuestions: 45 (none open) ( 2 without valid answers) ( 2 closed without grading) Answers: 0
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| | Lote-piloto / Lote em escala piloto | Explanation:
olá colega, veja por favor os dois links que lhe enviei, uma vez que não consegui "copiar" a informação do segundo... espero que lhe tenha ajudado!
What is the difference between a commercial and an exhibit batch?
A commercial batch is formulated or say manufactured at the production plant then what about the exhibit batch?
4. It is not mandatory to manufacture the Exhibit batch in the Production plant, but you must use identical/or essentially similar equipment. And this includes manufacturing vessel, transfer lines, filters, filling lines/needles, and so.
Regarding Scale-up/Exhibit batch, it is obvious that you cannot go ahead with an Exhibit batch until the Scale-up batch (including preliminary stabily) has been successful.
In relation to Exhibit/Commercial, and as mentioned before, Exhibit is the batch you will use to generate your stability data for submission and approval purposes, but please, do not intend to market this... Moreover, before you have 3 or 6-month stability data, and you have received approval, 2 years may have lapsed, so your product will be gone (assuming an initial 2-year shelf-life granted)...
This would be the main reason for not wasting material, money and time in doing a Commercial batch (x10 the size of an Exhibit), if this has to end in the bin...
5. • Exhibit batch is typically used to generate ICH stability data to submit your ANDA package, whereas commercial batches (it start with 3 validation batches) are followed later which are used to validate the process and you can sell FP from validation batches once ANDA application is approved.
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| Selected response from:
  Lídia Carney
United Kingdom
| Grading comment Thanks a lot Lídia!! It was really helpful!!
4 KudoZ points were awarded for this answer |
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| Discussion entries: 0 |
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Automatic update in 00:
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15 mins confidence:   Lote-piloto / Lote em escala piloto
Explanation:
olá colega, veja por favor os dois links que lhe enviei, uma vez que não consegui "copiar" a informação do segundo... espero que lhe tenha ajudado!
What is the difference between a commercial and an exhibit batch?
A commercial batch is formulated or say manufactured at the production plant then what about the exhibit batch?
4. It is not mandatory to manufacture the Exhibit batch in the Production plant, but you must use identical/or essentially similar equipment. And this includes manufacturing vessel, transfer lines, filters, filling lines/needles, and so.
Regarding Scale-up/Exhibit batch, it is obvious that you cannot go ahead with an Exhibit batch until the Scale-up batch (including preliminary stabily) has been successful.
In relation to Exhibit/Commercial, and as mentioned before, Exhibit is the batch you will use to generate your stability data for submission and approval purposes, but please, do not intend to market this... Moreover, before you have 3 or 6-month stability data, and you have received approval, 2 years may have lapsed, so your product will be gone (assuming an initial 2-year shelf-life granted)...
This would be the main reason for not wasting material, money and time in doing a Commercial batch (x10 the size of an Exhibit), if this has to end in the bin...
5. • Exhibit batch is typically used to generate ICH stability data to submit your ANDA package, whereas commercial batches (it start with 3 validation batches) are followed later which are used to validate the process and you can sell FP from validation batches once ANDA application is approved.
Reference: http://early-clinical-research.blogspot.com/2010/11/formulat...
Reference: http://www.oati.com.br/des/pdf/in_n2_2009.pdf
| Lídia Carney
United Kingdom
Works in field
Native speaker of:  Portuguese
PRO pts in category: 4
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| | Grading comment | Thanks a lot Lídia!! It was really helpful!! |
| | Login to enter a peer comment (or grade) |
26 mins confidence: peer agreement (net): +2 lotes de amostras
Explanation:
Encontrei este significado em espanhol
- Batch:
En la mayor parte de los casos puede traducirse sin problemas por ‘lote’ o ‘lote de fabricación’ (p. ej.: exhibit batch, lote de muestra), pero en ocasiones es preciso recurrir a otras posibilidades de traducción: batch injection calorimetry (calorimetría de inyección discontinua). ► La mayoría de los autores utilizan los términos batch y lot como si fueran sinónimos estrictos; en ocasiones, no obstante, se establece una diferencia entre batch (lote: cantidad total de un producto que se fabrica de una sola vez) y lot (partida o serie: cada una de las partes en que se subdivide un lote, envasadas, distribuidas y numeradas por separado).
medtrad.org/panacea/IndiceGeneral/n32_tradyterm_navarro.pdf
- Função & Características : SR 200 : Moinhos rotativos : Trituração ...O SR 300 foi pensado para uso universal: do preparo de amostras em laboratório até o preparo de lotes de amostras em plantas-piloto ou em instalações de ...
www.retsch.pt/pt/produtos/trituracao/moinhos.../sr-200/
- Em cache[DOC] Procedimento : enviar amostras - Index ofFormato do arquivo: Microsoft Word - Visualização rápida
3 mar. 2011 ... Para grandes lotes de amostras, comunicar o laboratório para definir o peso de envio mais adequado. - Amostras secas: colocar em sacos ou ...
www.lareal.com.br/user/index.php?option=com_joomdoc...doc.....
| Marcos Antonio
Local time: 14:22
Specializes in field
Native speaker of: Portuguese
PRO pts in category: 28
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| | Notes to answerer
Asker: Thanks a lot Marcos!!!
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| Changes made by editors |
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| May 12, 2011 - Changes made by Lídia Carney: | | Created KOG entry | KudoZ term => KOG term |
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