Reference Listed Drug [Regulatives / Guidelines]
Dear Kiran!
No guidance I know of. But you already justified it in your first post:
Of course its desirable to have the same batches (in order to perform a between studies comparison); especially for blockbusters it's unlikely that you get the same batch even after a couple of months. If you are lucky and more than one batch is on the market, try to make a selection matching the first batch (content, dissolution).
❝ Is there any guidance for the same or it is just a practice?
No guidance I know of. But you already justified it in your first post:
❝ due to unavailabilty of same batch of RLD used for fasting study.
Of course its desirable to have the same batches (in order to perform a between studies comparison); especially for blockbusters it's unlikely that you get the same batch even after a couple of months. If you are lucky and more than one batch is on the market, try to make a selection matching the first batch (content, dissolution).
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Reference Listed Drug kiranActimus 2011-05-11 10:36 [Regulatives / Guidelines]
- Reference Listed Drug Helmut 2011-05-11 11:35
- Reference Listed Drug kiranActimus 2011-05-11 11:50
- Reference Listed DrugHelmut 2011-05-11 11:59
- Reference Listed Drug kiranActimus 2011-05-11 12:12
- Reference Listed Drug luvblooms 2011-06-01 09:30
- Reference Listed Drug arpit.patel 2017-04-19 06:04
- Reference Listed Drug ElMaestro 2017-04-19 09:43
- Reference Listed Drug kiranActimus 2011-05-11 12:12
- Reference Listed DrugHelmut 2011-05-11 11:59
- Reference Listed Drug kiranActimus 2011-05-11 11:50
- Reference Listed Drug Helmut 2011-05-11 11:35