Log in
RegisterPlacebo in vitro [Study Performance]
Dear Tina
Intended market?
Canada or EU ?
Requirements are different for different regulatory authorities.
Health Canada:Asks for full API data (batch number, manufacturing process, Structure elucidation, impurities, stability, and almost full DMF information (restricted and un restricted part: you have to get an access letter from DMF supplier if DMF has been filed in Canada), Batch number used in manufacturing the clinical lot). Apart from this HC asks for full formulation information (not limiting to manufacturing process, Method of analysis, validation protocols, dissolution details, sufficient stability data of the formulation to be dosed to define the storage period (~3 month stability), impurities profile and many more thing.
EMEA: A bit lenient. If you have a lab batch data (specially 6 month stability)with similar composition, you can go ahead with the IMPD and CTA filing.
For Placebo also you need to give all the data related to excipients under use, their grade, TSE/BSE certificate, stability data, absence of API data, manufacturing process and other process related details.
Intended market?
Canada or EU ?
Requirements are different for different regulatory authorities.
Health Canada:Asks for full API data (batch number, manufacturing process, Structure elucidation, impurities, stability, and almost full DMF information (restricted and un restricted part: you have to get an access letter from DMF supplier if DMF has been filed in Canada), Batch number used in manufacturing the clinical lot). Apart from this HC asks for full formulation information (not limiting to manufacturing process, Method of analysis, validation protocols, dissolution details, sufficient stability data of the formulation to be dosed to define the storage period (~3 month stability), impurities profile and many more thing.
EMEA: A bit lenient. If you have a lab batch data (specially 6 month stability)with similar composition, you can go ahead with the IMPD and CTA filing.
For Placebo also you need to give all the data related to excipients under use, their grade, TSE/BSE certificate, stability data, absence of API data, manufacturing process and other process related details.
—
~A happy Soul~
~A happy Soul~
Complete thread:
- Placebo in vitro Tina 2013-06-10 04:47
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Placebo in vitro Helmut 2013-06-10 12:51
- Placebo in vitro Ohlbe 2013-06-10 14:48
- Placebo in vitro Dr_Dan 2013-06-11 09:39
- Placebo in vitro Tina 2013-06-11 13:28
- IMPD Helmut 2013-06-11 15:18
- No TOFU, pleeeze! Tina 2013-06-12 16:17
- IMPD Helmut 2013-06-11 15:18
- Placebo in vitro Tina 2013-06-11 13:28
- Placebo in vitroluvblooms 2013-06-17 07:40
- Placebo in vitro Helmut 2013-06-10 12:51
Ing. Helmut Schütz