Hydroxy urea RLD selection for EMA submission [Regulatives / Guidelines]
Dar All,
We are requesting for scientific advice on selection of RLD.
We are under development of drug product Hydroxyurea Oral Suspension for Europe Market.
As a part of our development program, we would like to seek your guidance on the selection of RLD for bioequivalence (BE) studies of Hydroxyurea Oral Suspension drug product. Specifically, we would like to request your technical advice for choice of RLD to be considered for the comparative BE i.e. RLD dosage form like Tablet, Capsules & Oral Solution to conduct the BE studies for our drug product which is oral suspension.
For your more information, we would like to let you know that we have been already procured Oral Solution as RLD and require your expert advice.
waiting for the valuable inputs...
Praful Rane
We are requesting for scientific advice on selection of RLD.
We are under development of drug product Hydroxyurea Oral Suspension for Europe Market.
As a part of our development program, we would like to seek your guidance on the selection of RLD for bioequivalence (BE) studies of Hydroxyurea Oral Suspension drug product. Specifically, we would like to request your technical advice for choice of RLD to be considered for the comparative BE i.e. RLD dosage form like Tablet, Capsules & Oral Solution to conduct the BE studies for our drug product which is oral suspension.
For your more information, we would like to let you know that we have been already procured Oral Solution as RLD and require your expert advice.
waiting for the valuable inputs...
Praful Rane
Complete thread:
- Hydroxy urea RLD selection for EMA submissionPraful Rane 2025-07-29 11:08
- No RLD in the EEA Helmut 2025-07-29 12:36
