Glossary entry (derived from question below)
English term or phrase:
Powder-in-bottle (PIB)
Portuguese translation:
pó para reconstituição
Added to glossary by
Matheus Chaud
Sep 10, 2018 19:18
5 yrs ago
1 viewer *
English term
Powder-in-bottle (PIB)
English to Portuguese
Medical
Medical: Health Care
Clinical
Powder-in-bottle formulation of SU011248. Enabling rapid progression into human clinical trials.
The powder-in-bottle (PIB) approach was used to accelerate development and introduction into Phase I clinical trials. This approach consists of extemporaneously compounding the active pharmaceutical ingredient (API) into a solution or a suspension in the clinic prior to oral administration. The development consisted of physico-chemical assessment, constitution fluid selection, weighing and dosing validation, and stability evaluation of API, before and after constitution with the fluid. Of the oral liquids evaluated, apple juice was selected as the constitution fluid.
Dosing validation studies showed complete recovery of SU011248 from the bottle over a dose range of 10 to 2200 mg. SU011248 is stable as the solid API. Following constitution with apple juice, the product is stable through the predicted duration of compounding and dosing at the clinical site. This approach provided a high degree of dosing flexibility during the initial phase of clinical trials. Additionally, the PIB approach reduced the time and API required for clinical development and supplies to < 2 months and < 100 gm, respectively.
The powder-in-bottle (PIB) approach was used to accelerate development and introduction into Phase I clinical trials. This approach consists of extemporaneously compounding the active pharmaceutical ingredient (API) into a solution or a suspension in the clinic prior to oral administration. The development consisted of physico-chemical assessment, constitution fluid selection, weighing and dosing validation, and stability evaluation of API, before and after constitution with the fluid. Of the oral liquids evaluated, apple juice was selected as the constitution fluid.
Dosing validation studies showed complete recovery of SU011248 from the bottle over a dose range of 10 to 2200 mg. SU011248 is stable as the solid API. Following constitution with apple juice, the product is stable through the predicted duration of compounding and dosing at the clinical site. This approach provided a high degree of dosing flexibility during the initial phase of clinical trials. Additionally, the PIB approach reduced the time and API required for clinical development and supplies to < 2 months and < 100 gm, respectively.
Proposed translations
(Portuguese)
4 +2 | pó para reconstituição | Matheus Chaud |
3 | formulação / método PIB | Oliver Simões |
References
sunitinib (SU 011248) | José Patrício |
Change log
Sep 24, 2018 12:00: Matheus Chaud Created KOG entry
Proposed translations
+2
1 day 1 hr
Selected
pó para reconstituição
No Brasil, pelo que pesquisei, fala-se em pós para reconstituição:
https://edisciplinas.usp.br/pluginfile.php/3303123/mod_resou...
pós para reconstituição que resultem em soluções aquosas...
https://farmacia.hc.ufg.br/up/734/o/MAN_001-12_Reconstituiçã...
...informações relativas ao processo de reconstituição do pó
4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
2 hrs
formulação / método PIB
Desconheço um termo técnico para isso. Sugiro manter a abreviatura e acrescentar uma nota explicativa de rodapé. Algo assim:
O método / formulação PIB (do inglês Powder-in-Bottle) consiste em combinar (ou misturar) antecipadamente o ingrediente (farmacêutico) ativo, em forma de pó (powder), numa solução ou suspensão em frasco (bottle) na clínica em que se realiza o ensaio antes da administração oral. (NT)
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Note added at 2 hrs (2018-09-10 22:11:57 GMT)
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É possível que não haja necessidade de uma nota de rodapé, uma vez que o próprio texto já explica o significado da abreviatura.
O método / formulação PIB (do inglês Powder-in-Bottle) consiste em combinar (ou misturar) antecipadamente o ingrediente (farmacêutico) ativo, em forma de pó (powder), numa solução ou suspensão em frasco (bottle) na clínica em que se realiza o ensaio antes da administração oral. (NT)
--------------------------------------------------
Note added at 2 hrs (2018-09-10 22:11:57 GMT)
--------------------------------------------------
É possível que não haja necessidade de uma nota de rodapé, uma vez que o próprio texto já explica o significado da abreviatura.
Reference comments
2 hrs
Reference:
sunitinib (SU 011248)
inibidor multi-alvos da tirosina quinase, sunitinib (SU 011248):
o inibidor multi-alvos da tirosina quinase, sunitinib (SU 011248). - http://gpgu.org/wp-content/uploads/2011/06/recomendacoes-ter...
o inibidor multi-alvos da tirosina quinase, sunitinib (SU 011248). - http://gpgu.org/wp-content/uploads/2011/06/recomendacoes-ter...
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