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forma farmacéutica

English translation: dosage/pharmaceutical form

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:forma farmacéutica
English translation:dosage/pharmaceutical form
Entered by: Kimberlee Thorne-Harper
Options:
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00:28 Dec 9, 2010
Spanish to English translations [PRO]
Medical - Medical: Pharmaceuticals / editing a pharmaceutical file from Mexican Spanish to US English
Spanish term or phrase: forma farmacéutica
I'm editing some pharmaceutical norms. The translator has used "Dosage form" for this phrase. Please let me know if it's correct or if another option would be better. Thanks in advance!

Forma farmacéutica.
Es evidente que la forma farmacéutica esta implícita en la IPP o
monografía del producto, no será necesario repetirla.
Es necesario realizar un PSUR para cada forma farmacéutica, ya que
éstas cuentan con un registro diferente, éste reporte deberá incluir
todas las presentaciones de ese producto.
Por ejemplo: se tiene un medicamento autorizado como tabletas,
supositorios y suspensión será diferente PSUR para cada forma
farmacéutica, aunque se trate del mismo principio activo.
Si el medicamento en tabletas cuenta con diferentes presentaciones
como dosis de 200mg, 400mg y 800mg los datos deberán ser
explícitos en el mismo PSUR, incluyendo aquellos que sean genéricos
intercambiables (tengan o no el mismo número de registro).
Nota: No enviar PSUR de principios activos iguales y de diferentes
formas farmacéuticas en uno solo.

Translation:


Dosage form.

It is clear that the dosage form is implicit in the PPI or product monograph, so it is not necessary to repeat it.

A PSUR is needed for each dosage form, as they each have a different registration. This report shall will include all presentations of the product.


For example: for a drug approved as tablets, suppositories and suspension, the PSUR will be different for each dosage form, even if they have the same active ingredient.


If the drug in tablets has different presentations in 200mg, 400mg and 800mg doses, the data shall be made explicit in the same PSUR, including those that are interchangeable generic products (whether or not they have the same registration number).


Note: Do not submit reports on active ingredients and dosage forms in a single PSUR.
Kimberlee Thorne-Harper
United States
Local time: 02:51
dosage/pharmaceutical form
Explanation:
http://www.google.it/search?hl=it&newwindow=1&q="pharmaceuti...

http://en.wikipedia.org/wiki/Dosage_form

... A dosage form (DF) is the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. Common dosage forms include pill, tablet, or capsule, drink or syrup, aerosol or inhaler, liquid injection, pure powder or solid crystal (e.g., via oral ingestion or freebase smoking), and natural or herbal form such as plant or food of sorts, among many others. Notably, the route of administration (ROA) for drug delivery is dependent on the dosage form of the substance in question.

Various dosage forms may exist for a single particular drug, since different medical conditions can warrant different routes of administration. For example, persistent nausea and emesis or vomiting may make it difficult to use an oral dosage form, and in such a case, it may be necessary to utilize an alternate route such as inhalational, buccal, sublingual, nasal, suppository, or parenteral instead.

Additionally, a specific dosage form may be a requirement for certain kinds of drugs, as there may be issues with various factors like chemical stability or pharmacokinetics. As an example, insulin cannot be given orally because upon being administered in this manner, it is extensively metabolized in the gastrointestinal tract (GIT) before reaching the blood stream, and is thereby incapable of sufficiently reaching its therapeutic target destinations.

Contents [hide]
1 Types
1.1 Oral
1.2 Inhalational
1.3 Parenteral Injection
1.4 Topical
1.5 Suppository
2 See also
3 References
4 External links


[edit] Types
[edit] Oral
Pill, tablet, or capsule
Specialty tablet like buccal, sublingual, or orally-disintegrating
Thin film (e.g., Listerine PocketPaks)
Liquid solution or suspension (e.g., drink or syrup)
Powder or liquid or solid crystals
Natural or herbal plant, seed, or food of sorts (e.g., marijuana such as that found in "special brownies")
[edit] Inhalational
Aerosol
Inhaler
Nebulizer
Smoking (often in natural herb (e.g., tobacco, marijuana) or freebase powder form (e.g., cocaine, methamphetamine)
Vaporizer (usually to vaporize natural herbs like marijuana)
[edit] Parenteral Injection
Intradermal (ID)
Intramuscular (IM)
Intraosseous (IR)
Intraperitoneal (IP)
Intravenous (IV)
Subcutaneous (SC)
[edit] Topical
Cream, gel, liniment or balm, lotion, or ointment, etc
Ear drops (otic)
Eye drops (ophthalmic)
Skin patch (transdermal)
[edit] Suppository
Rectal (e.g., enema)
Vaginal (e.g., douche, pessary, etc) ...

--------------------------------------------------
Note added at 17 min (2010-12-09 00:45:42 GMT)
--------------------------------------------------

http://www.google.it/search?hl=it&newwindow=1&q="pharmaceuti...

In English, **pharmaceutical form** is more correct and comprehensive, and surely more common:)

--------------------------------------------------
Note added at 7 giorni (2010-12-16 09:24:16 GMT) Post-grading
--------------------------------------------------

Thanks to all the agreeing colleagues, and Happy Holidays!, Anna Rosa
Selected response from:

ARS54
Italy
Local time: 10:51
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +9dosage/pharmaceutical form
ARS54
4 +1dosage form
Charles Davis


Discussion entries: 2





  

Answers


13 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
dosage form


Explanation:
Yes, I believe dosage form is the correct translation of forma farmacéutica.

A dosage form (DF) is the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. Common dosage forms include pill, tablet, or capsule, drink or syrup, aerosol or inhaler, liquid injection, pure powder or solid crystal (e.g., via oral ingestion or freebase smoking), and natural or herbal form such as plant or food of sorts, among many others.
http://en.wikipedia.org/wiki/Dosage_form

Forma galénica o forma farmacéutica es la disposición individualizada a que se adaptan los fármacos (principios activos) y excipientes (materia farmacológicamente inactiva) para constituir un medicamento.[1] O dicho de otra forma, la disposición externa que se da a las sustancias medicamentosas para facilitar su administración.
http://es.wikipedia.org/wiki/Medicamento

--------------------------------------------------
Note added at 2 hrs (2010-12-09 02:36:19 GMT)
--------------------------------------------------

Yes indeed, "pharmaceutical form" is fine too. But I can't see any good reason for the asker to change "dosage form" to "pharmaceutical form" in the translation she is editing. As far as I can tell they are synonymous (if anyone knows of a substantive difference that is relevant here it would be useful to know it). I see no evidence that "pharmaceutical form" is more correct in this context, and I think it is clearly less common in the field, though by no means rare.

--------------------------------------------------
Note added at 2 hrs (2010-12-09 02:57:16 GMT)
--------------------------------------------------

By the way, there is an entertaining and enlightening debate on this very issue back a couple of years ago: http://www.proz.com/kudoz/english_to_spanish/medical:_pharma...

--------------------------------------------------
Note added at 9 hrs (2010-12-09 09:34:29 GMT)
--------------------------------------------------

Well, such strong support for "pharmaceutical form" among competent specialists is very compelling, and I'd better withdraw here as gracefully as I can!

--------------------------------------------------
Note added at 9 hrs (2010-12-09 09:38:07 GMT)
--------------------------------------------------

But I would be very interested to know whether there it is more correct because of a difference in meaning (for example, does "pharmaceutical form" refer to the route of administration as well as the physical form of the drug?), or just because it is currently the favoured synonym.

Charles Davis
Spain
Local time: 10:51
Native speaker of: Native in EnglishEnglish
PRO pts in category: 124

Peer comments on this answer (and responses from the answerer)
agree  philgoddard: Pharmaceutical form is fine too.
10 mins
  -> Thanks, Phil :)
Login to enter a peer comment (or grade)

14 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +9
dosage/pharmaceutical form


Explanation:
http://www.google.it/search?hl=it&newwindow=1&q="pharmaceuti...

http://en.wikipedia.org/wiki/Dosage_form

... A dosage form (DF) is the physical form of a dose of a chemical compound used as a drug or medication intended for administration or consumption. Common dosage forms include pill, tablet, or capsule, drink or syrup, aerosol or inhaler, liquid injection, pure powder or solid crystal (e.g., via oral ingestion or freebase smoking), and natural or herbal form such as plant or food of sorts, among many others. Notably, the route of administration (ROA) for drug delivery is dependent on the dosage form of the substance in question.

Various dosage forms may exist for a single particular drug, since different medical conditions can warrant different routes of administration. For example, persistent nausea and emesis or vomiting may make it difficult to use an oral dosage form, and in such a case, it may be necessary to utilize an alternate route such as inhalational, buccal, sublingual, nasal, suppository, or parenteral instead.

Additionally, a specific dosage form may be a requirement for certain kinds of drugs, as there may be issues with various factors like chemical stability or pharmacokinetics. As an example, insulin cannot be given orally because upon being administered in this manner, it is extensively metabolized in the gastrointestinal tract (GIT) before reaching the blood stream, and is thereby incapable of sufficiently reaching its therapeutic target destinations.

Contents [hide]
1 Types
1.1 Oral
1.2 Inhalational
1.3 Parenteral Injection
1.4 Topical
1.5 Suppository
2 See also
3 References
4 External links


[edit] Types
[edit] Oral
Pill, tablet, or capsule
Specialty tablet like buccal, sublingual, or orally-disintegrating
Thin film (e.g., Listerine PocketPaks)
Liquid solution or suspension (e.g., drink or syrup)
Powder or liquid or solid crystals
Natural or herbal plant, seed, or food of sorts (e.g., marijuana such as that found in "special brownies")
[edit] Inhalational
Aerosol
Inhaler
Nebulizer
Smoking (often in natural herb (e.g., tobacco, marijuana) or freebase powder form (e.g., cocaine, methamphetamine)
Vaporizer (usually to vaporize natural herbs like marijuana)
[edit] Parenteral Injection
Intradermal (ID)
Intramuscular (IM)
Intraosseous (IR)
Intraperitoneal (IP)
Intravenous (IV)
Subcutaneous (SC)
[edit] Topical
Cream, gel, liniment or balm, lotion, or ointment, etc
Ear drops (otic)
Eye drops (ophthalmic)
Skin patch (transdermal)
[edit] Suppository
Rectal (e.g., enema)
Vaginal (e.g., douche, pessary, etc) ...

--------------------------------------------------
Note added at 17 min (2010-12-09 00:45:42 GMT)
--------------------------------------------------

http://www.google.it/search?hl=it&newwindow=1&q="pharmaceuti...

In English, **pharmaceutical form** is more correct and comprehensive, and surely more common:)

--------------------------------------------------
Note added at 7 giorni (2010-12-16 09:24:16 GMT) Post-grading
--------------------------------------------------

Thanks to all the agreeing colleagues, and Happy Holidays!, Anna Rosa

Example sentence(s):
  • Code / Pharmaceutical Form. AEM: Aerosol metered-dose; AER: Aerosol with propellants; BAR: Bar chewable; BEA: Bead; BIS: Biscuit; BLS: Bolus ...
  • The Pharmaceutical Form is the combination of the form in which a medicinal product is presented by the manufacturer (form of presentation) and the form in ...

    Reference: http://www.hc-sc.gc.ca
    Reference: http://www.euromedstat.cnr.it
ARS54
Italy
Local time: 10:51
Specializes in field
Native speaker of: Native in ItalianItalian
PRO pts in category: 22

Peer comments on this answer (and responses from the answerer)
agree  Claudia Reynaud: pharmaceutical form is the correct term
1 hr
  -> ...true, Claudia, thanks a lot (see my Note)!, Anna Rosa

agree  David Brown: yes, pharmaceutical form is correct and the standard
6 hrs
  -> Thank you very much, David, and HAGD, AR

agree  daria fedele
6 hrs
  -> Thanks so much, dearest, besos y HAGL!, R.

agree  Emma Goldsmith: pharmaceutical form
7 hrs
  -> Thank you, Emma!, HAGD, AR

agree  petra jessner: d'accordo dottoressa! hdl!
7 hrs
  -> Ciao, mein liebe, grazie e hdl!, R.

agree  liz askew: pharmaceutical form. This has come up before
7 hrs
  -> Thank you liz, AR

agree  Muriel Vasconcellos: pharmaceutical form - that's the standard
7 hrs
  -> ...As said, thanks!, AR

agree  xxxNKW: Pharmaceutical form, definitely
7 hrs
  -> Thanks! AR

agree  AeC2009
1 day 9 hrs
  -> ...Hola, qué tal! Todo bien? Muchas gracias!, R.
Login to enter a peer comment (or grade)




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