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  3. Medical: Pharmaceuticals

bridging [study/report]

Romanian translation: studiu/raport suplimentar (complementar/de complementaritate)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:bridging [study/report]
Romanian translation:studiu/raport suplimentar (complementar/de complementaritate)
Entered by: Cristina Frasineanu

12:40 Apr 7, 2011
English to Romanian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: bridging [study/report]
However, sometimes an effect on efficacy and/or safety can be expected or cannot be ruled out in spite of a state
of the art physico-chemical and biological tests. In such cases, additional non-clinical and clinical
studies will be necessary. The type and extent of such studies are variable and will dependent on
numerous factors related to the drug substance and the drug product, to findings in the comparability
exercise as well as to its clinical use.
This is a sequential process, beginning with quality studies (limited or comprehensive) and supported,
as necessary, by non-clinical and/or clinical bridging studies.
This guideline will address the requirements for non-clinical and/or clinical bridging studies to
demonstrate that the modification has no impact on safety and efficacy profile.

The summary bridging report is a concise document integrating the information presented in two or more PSURs to cover a specified period over which a single report is requested (e.g. 2 consecutive 6-monthly reports for a yearly PSUR, 6 consecutive 6-monthly PSURs, or a combination of 6-monthly and yearly PSURs to make up a 3 year report).
The summary bridging report should include summary highlights bridging two or more PSURs and an overview of data from the attached PSURs to which it refers. The format should be identical to that of the usual PSUR.
The summary bridging report should not include new data or line listings. Moreover, PSUR data should not be repeated, but cross-referred to individual PSURs. However the clinical overview should contain a discussion about safety data as it would be included in such summary bridging report.

The
MAH did however submit a bridging report making reference to the user test results.
Cristina Frasineanu
Local time: 03:33
studiu/raport suplimentar
Explanation:
A bridging study is defined as a supplemental study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the new region. Such studies could include additional pharmacokinetic information.
www.amstat.org/meetings/fdaworkshop/.../P3_Chow_Bridging.pp...
Selected response from:

Mihaela Petrican
Italy
Local time: 02:33
Grading comment
Multumesc!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +4studiu/raport suplimentar
Mihaela Petrican


  

Answers


1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +4
studiu/raport suplimentar


Explanation:
A bridging study is defined as a supplemental study performed in the new region to provide pharmacodynamic or clinical data on efficacy, safety, dosage, and dose regimen in the new region that will allow extrapolation of the foreign clinical data to the new region. Such studies could include additional pharmacokinetic information.
www.amstat.org/meetings/fdaworkshop/.../P3_Chow_Bridging.pp...


Mihaela Petrican
Italy
Local time: 02:33
Specializes in field
Native speaker of: Native in RomanianRomanian
PRO pts in category: 650
Grading comment
Multumesc!

Peer comments on this answer (and responses from the answerer)
agree  Cosmin Băduleţeanu
7 mins
  -> mulţumesc :)
agree  Irina-Maria Foray
3 hrs
  -> mulţumesc :)
agree  Julia Prazsmary
19 hrs
  -> mulţumesc :)
agree  Iosif JUHASZ
2 days 18 hrs
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