Bioequivalent Drugs: Towards A Needed HolisticParadigm Shift? by François-Xavier Lacasse in DDIPIJ in Lupine Publishers.
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 (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. However, the goal of this current
expert opinion is not to generate conflicts, or to compare generic
versus innovator drugs in the sense that one is better than the other. To know more click on below link.
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