Bioequivalence and Bioavailability Forum • Pharmacokinetics linearity

Pharmacokinetics linearity [Regulatives / Guidelines]

posted by pjs – India, 2015-05-20 12:25 (3641 d 19:00 ago) – Posting: # 14854
Views: 5,793

Dear all,

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.

If we develop oral solution which is Q1 same and Q2 similar (no excipient affecting GI motility/similar to generic). How can we prove linearity for 5mg/5ml strength and get biowaiver?

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