Mar 13, 2012 15:58
12 yrs ago
28 viewers *
English term
bridging study
English
Medical
Medical (general)
cancer studies
BRCA Sequencing: bridging study
[what does it mean exatly and what has this to do with bridge or bridging?]
[what does it mean exatly and what has this to do with bridge or bridging?]
Responses
4 | comparative extrapolative study |
Daniel Grigoras
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3 | study of different changes (bridging sequences) in DNA modification |
Stephanie Ezrol
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References
Comparability Bridging Study |
Kim Metzger
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Responses
2 hrs
Selected
comparative extrapolative study
"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...
"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...
4 KudoZ points awarded for this answer.
Comment: "Thank you!"
32 mins
study of different changes (bridging sequences) in DNA modification
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.
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.
Reference comments
28 mins
Reference:
Comparability Bridging Study
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...
http://www.ema.europa.eu/docs/en_GB/document_library/Scienti...
Discussion