Mar 13, 2012 15:58
12 yrs ago
29 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
|
| 3 | study of different changes (bridging sequences) in DNA modification |
Stephanie Ezrol
|
References
| Comparability Bridging Study |
Kim Metzger
|
Responses
2 hrs
Daniel Grigoras
Romania
Romania
Romania
Per aspera ad astra
Native in: Romanian (Variant: Romania)
Works in: Romanian to English, English to Romanian, English, and 1 more.
Related KudoZ points
:
8
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
Stephanie Ezrol
United States
United States
Native in English
&
English
United States
French to English, English to English
Native in: English
Works in: English, French to English, French Middle (ca.1400-1600) to English
Related KudoZ points
:
48
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
Kim Metzger
Mexico
Mexico
Native in English
&
English
Mexico
Committed to Quality and Service
Native in: English (Variant: US) 
Works in: German to English
Related KudoZ points
:
22
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