Bioequivalence and Bioavailability Forum • Type of studies etc.

nvs
☆

India,
2008-02-19 08:11
(5909 d 01:06 ago)

(edited by Ohlbe on 2008-02-19 21:46)
Posting: # 1621
Views: 3,009

Type of studies etc. [Dissolution / BCS / IVIVC]

Dear all,
Anybody let me know about flow for in-vitro studies, In which stage of drug designing we have to take approval for in-vitro studies for both innovative & generic drugs.
Which parameters we have to do?
Do we conduct in-vitro studies separately with different mechanism (different in-vitro parameters) for generic & innovative drugs.
What are the common parameters for generic & innovative drugs (in in-vitro studies)
pz share any guidelines regarding this.

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Edit: Category changed. [Ohlbe]
Edit: Subject line altered. [Helmut]