Pharmacokinetics linearity [Regulatives / Guidelines]
Dear all,
What information may be needed to extrapolate linearity for the oral solution dosage form.
Drug is BCS class 3
Has been used in the general population for more than 10 years and the submission is for Europe.
Regards,
PJS
What information may be needed to extrapolate linearity for the oral solution dosage form.
- Innovator has developed tablet and has established linearity in the dose range e.g. 10-200mg (oral) and 2-10 mg (IV).
- Generic oral solution has been available in the strength of 5mg/5ml and 25 mg/5ml.
Drug is BCS class 3
Has been used in the general population for more than 10 years and the submission is for Europe.
Regards,
PJS
Complete thread:
- Pharmacokinetics linearitypjs 2015-05-20 10:25 [Regulatives / Guidelines]
- Pharmacokinetics linearity pjs 2015-05-28 12:26
- Pharmacokinetics linearity nobody 2015-05-28 13:44
- Pharmacokinetics linearity ElMaestro 2015-05-28 14:14
- Pharmacokinetics linearity Dr_Dan 2015-05-28 14:32
- Pharmacokinetics linearity pjs 2015-05-28 14:58
- Pharmacokinetics linearity nobody 2015-05-28 15:50
- Pharmacokinetics linearity pjs 2015-05-28 16:11
- Pharmacokinetics linearity Dr_Dan 2015-05-29 09:03
- Pharmacokinetics linearity pjs 2015-05-28 16:11
- Pharmacokinetics linearity nobody 2015-05-28 15:50
- Pharmacokinetics linearity pjs 2015-05-28 14:58
- Pharmacokinetics linearity Dr_Dan 2015-05-28 14:32
- Pharmacokinetics linearity ElMaestro 2015-05-28 14:14
- Pharmacokinetics linearity nobody 2015-05-28 13:44
- Pharmacokinetics linearity pjs 2015-05-28 12:26