Abstract
The author of this short communication has been working in and teaching drug development for the last 20 years. He has been involved in more than 100 drug development projects, including drug delivery, medical device, biologics, innovators and generic drugs. He has also been involved in all the steps that are needed to file properly to different governmental agencies investigational new drug applications .
Highlights
The author of this short communication has been working in and teaching drug development for the last 20 years. He has been involved in more than 100 drug development projects, including drug delivery, medical device, biologics, innovators and generic drugs. He has been involved in all the steps that are needed to file properly to different governmental agencies investigational new drug applications (IND), clinical trial applications (CTA), abbreviated and new drug applications/submissions (ANDA\S; NDA/S), 505b2, 510k and biologics legal applications (BLA)
After several other interactions with all the other actors, such as Health Canada (HC), the Food and Drug Agency (FDA), the European Medicines Agency (EMA), pharmacovigilance companies and consultants, public relation companies, insurance companies and especially patients, the author has decided to gather all the comments in order to initiate a kind of a new debate on the innovators and generic drugs
The author has already been involved in several bioequivalence studies, comparing two innovator products where the results showed lack of bioequivalence....or in bioequivalence studies evaluated with clinical endpoint where generic drug products were more potent than the innovators...The goal of this paper should be more based on the following question: are the current methods used to assess bioequivalence are suitable and reliable enough to “stamp” that generic drugs are bioequivalent, are as stable, reliable form a quality, a safety and efficacy standpoints
Summary
The author of this short communication has been working in and teaching drug development for the last 20 years. The author has already been involved in several bioequivalence studies, comparing two innovator products where the results showed lack of bioequivalence....or in bioequivalence studies evaluated with clinical endpoint where generic drug products were more potent than the innovators...The goal of this paper should be more based on the following question: are the current methods used to assess bioequivalence are suitable and reliable enough to “stamp” that generic drugs are bioequivalent, are as stable, reliable form a quality, a safety and efficacy standpoints.
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