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Powder-in-bottle (PIB)

Portuguese translation: pó para reconstituição

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Powder-in-bottle (PIB)
Portuguese translation:pó para reconstituição
Entered by: Matheus Chaud

19:18 Sep 10, 2018
English to Portuguese translations [PRO]
Medical - Medical: Health Care / Clinical
English term or phrase: Powder-in-bottle (PIB)
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.
Fernando Petracioli
Brazil
Local time: 18:10
pó para reconstituição
Explanation:

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
Selected response from:

Matheus Chaud
Brazil
Local time: 18:10
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2pó para reconstituição
Matheus Chaud
3formulação / método PIB
Oliver Simões
Summary of reference entries provided
sunitinib (SU 011248)
José Patrício

  

Answers


2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
formulação / método PIB


Explanation:
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)

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

Oliver Simões
United States
Local time: 14:10
Specializes in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 28
Login to enter a peer comment (or grade)

1 day 1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
powder-in-bottle (PIB)
pó para reconstituição


Explanation:

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

Matheus Chaud
Brazil
Local time: 18:10
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 48
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Maria Teresa Borges de Almeida
14 hrs
  -> Obrigado, Teresa!
agree  Margarida Ataide
17 hrs
  -> Obrigado, Margarida!
Login to enter a peer comment (or grade)




Reference comments


2 hrs
Reference: sunitinib (SU 011248)

Reference information:
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...

José Patrício
Portugal
Native speaker of: Native in PortuguesePortuguese
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