1 00:00:00,080 --> 00:00:04,920 SILENCE 2 00:00:05,080 --> 00:00:08,080 We're performing this research because there is a lot of public debate 3 00:00:08,240 --> 00:00:11,520 about efficacy, safety and quality of generic medicines. 4 00:00:11,680 --> 00:00:14,560 And for the registration of generic medicines, 5 00:00:14,720 --> 00:00:17,120 bioequivalence needs to be proven. 6 00:00:17,280 --> 00:00:20,200 And we are challenging the concept of bioequivalence. 7 00:00:20,360 --> 00:00:23,040 Is that still the best way to register generics? 8 00:00:23,800 --> 00:00:28,480 The research is still ongoing. We're not sure yet what this means for the patient. 9 00:00:28,640 --> 00:00:31,960 Basically, there are two possible outcomes for this research. 10 00:00:32,120 --> 00:00:35,920 First would be that this supports the current policy and regulations 11 00:00:36,080 --> 00:00:38,080 for the registration of generics. 12 00:00:38,240 --> 00:00:40,720 Second would be that we would indicate some flaws 13 00:00:40,880 --> 00:00:43,960 in the system and regulatory requirements. 14 00:00:44,120 --> 00:00:47,280 So then, we're challenged to look at improvements of the system. 15 00:00:47,440 --> 00:00:51,720 Either way, the patient or the healthcare professional can be ensured 16 00:00:51,880 --> 00:00:55,600 that we challenge the concept of bioequivalence and make sure 17 00:00:55,760 --> 00:01:01,560 that the best possible way of registration of generics is in practice. 18 00:01:02,320 --> 00:01:04,600 To get to these results, uh... 19 00:01:04,760 --> 00:01:08,680 together with University Maastricht and Radboud University, 20 00:01:08,840 --> 00:01:12,240 we started a collaboration with the University of Southern California 21 00:01:12,400 --> 00:01:14,480 to learn about pharmacokinetic modelling. 22 00:01:14,640 --> 00:01:18,480 And we applied this mathematical modelling to a bioequivalence study 23 00:01:18,640 --> 00:01:21,160 with four different formulations of Gabapentin, 24 00:01:21,320 --> 00:01:24,400 of which one is the originator, and there are three generics. 25 00:01:24,560 --> 00:01:27,160 Now, if we look at the second picture on the poster, 26 00:01:27,320 --> 00:01:29,600 this picture represents actually 27 00:01:29,760 --> 00:01:35,120 the estimated absorption constant values per subject, colour-coded per formulation. 28 00:01:35,280 --> 00:01:39,400 So, if this were the result of the research, there would actually be 29 00:01:39,560 --> 00:01:44,600 an altered absorption profile estimated for one of the formulations. 30 00:01:45,440 --> 00:01:49,800 But again, this is preliminary research, and the research is still ongoing.