bridging study
English translation: comparative extrapolative study
| 15:58 Mar 13, 2012 |
| English language (monolingual) [PRO] Medical - Medical (general) / cancer studies | |||||||
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|  Selected response from: Daniel Grigoras Romania | ||||||
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| SUMMARY OF ALL EXPLANATIONS PROVIDED | ||||
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| 4 | comparative extrapolative study |
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| 3 | study of different changes (bridging sequences) in DNA modification |
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| Summary of reference entries provided | |||
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| Comparability Bridging Study |
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| Discussion entries: 1 | |
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Answers
32 mins confidence: 
study of different changes (bridging sequences) in DNA modification Explanation: I am not an expert in the field, but I do have a background in biology and chemistry. I believe they are discussing genetic modifications in BRCA gene. The bridging sequences seem to be possible modifications in the gene. The following reference is my sources for saying that: "The mutant Δ1–170 was created by deleting the same 0.5-kb NotI/AatII fragment from BRCA1 and inserting a 29-bp bridging sequence made by annealing the complementary synthetic oligonucleotides BH9924 and BH9925. " http://www.jbc.org/content/275/49/38589.full There is much more on the internet about BRCA along the same lines. The full article noted above should be helpful to you. |
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2 hrs confidence:
comparative extrapolative study 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." (http://www.google.ro/url?sa=t&rct=j&q=&esrc=s&source=web&cd=... - a bit incoherent "A study performed to provide nonclinical or clinical data that allows extrapolation of the existing data from the drug product produced by the current process to the drug product from the changed process." (http://www.ema.europa.eu/docs/en_GB/document_library/Scienti... |
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Reference comments
28 mins |
| Reference: Comparability Bridging Study Reference information: A study performed to provide nonclinical or clinical data that allows extrapolation of the existing data from the drug product produced by the current process to the drug product from the changed process. http://www.ema.europa.eu/docs/en_GB/document_library/Scienti... |
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