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RegisterNevirapine ER tablets [Regulatives / Guidelines]
Dear All,
What are the studies required for Nevirapine Extended Release tablets for Europe regulatory?
Strengths available are 50 mg, 100 mg, 400 mg.
Since product is single unit Extended Release Tablet, as per guidelines single dose fasting studies for 50 mg, 100 mg and 400 mg are required.
Single dose Fed study for 400 mg and Multiple dose fasting study on 400 mg required.
Upon multiple dose administration, risk of Nevirapine toxicity in healthy volunteers (May be for all strengths also).
If multiple dose study in HIV patients, may need to give other ARV’s as a concomitant medication.
Please suggest the multiple dose study in this case.
Regards
Kotu.
What are the studies required for Nevirapine Extended Release tablets for Europe regulatory?
Strengths available are 50 mg, 100 mg, 400 mg.
Since product is single unit Extended Release Tablet, as per guidelines single dose fasting studies for 50 mg, 100 mg and 400 mg are required.
Single dose Fed study for 400 mg and Multiple dose fasting study on 400 mg required.
Upon multiple dose administration, risk of Nevirapine toxicity in healthy volunteers (May be for all strengths also).
If multiple dose study in HIV patients, may need to give other ARV’s as a concomitant medication.
Please suggest the multiple dose study in this case.
Regards
Kotu.
Complete thread:
- Nevirapine ER tabletsbalakotu 2014-07-02 08:50 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Nevirapine ER tablets Ohlbe 2014-07-04 16:16
- Nevirapine ER tablets balakotu 2014-07-05 11:42
- Nevirapine ER tablets Ohlbe 2014-07-04 16:16
Ing. Helmut Schütz