types and compliance of the bioequivalence

	2009	2010	2011
Applications with bioequivalence information
Number	11	62	118
Rate (% in relation with the total number of applications)	8.7 %	39.9 %	57.3 %
Types of bioequivalence documentations and rates of compliance
In vivo comparative pharmacokinetic studies	72.7%	79.0%	37.3%
In vivo comparative clinical trial	0.0%	3.2%	0.0%
In vitro comparative dissolution tests	9.1%	19.4%	54.2%
Simple in vitro simple dissolution tests	18.2%	0.0%	0.0%
Total rate of compliance	100	98.4*	81.5*

*The non compliant data found in 2010 and 2011 only concerned the comparative dissolution tests.

Table 2: Rates, types and compliance of the bioequivalence documentations submitted in 2009, 2010 and 2011 for the registration of generic oral capsule and tablet dosage forms.

Goto home»