Global Harmonization of Drug Development — A Clinical Statistics Perspective

2019 ◽  
pp. 348-367
Keyword(s):  
Drug Development ◽  
Clinical Statistics ◽  
Global Harmonization

Regulatory sciences and translational pharmacogenetics: amitriptyline as a case in point

2019 ◽  
Vol 34 (2) ◽  
Author(s):  
Luana Mifsud Buhagiar ◽  
Benjamin Micallef ◽  
John Joseph Borg ◽  
Helen Vella ◽  
Anthony Serracino Inglott ◽  
...  
Keyword(s):  
Drug Development ◽  
Genomic Research ◽  
Clinical Implementation ◽  
Safety Concerns ◽  
Global Harmonization ◽  
Regulatory Sciences ◽  
Product Literature

Abstract Regulatory developments and clinical implementation, or the lack thereof, are primary clinchers, in the enduring endeavors to realize the translational quality of pharmacogenetics. Here, we present the case of amitriptyline, an established drug with pharmacogenetic implications. The integration of pharmacogenetic information in the official product literature and throughout the evaluation of safety concerns is considered. In our opinion, apart from emboldening genomic research in drug development and the valid pursuit towards global harmonization in the field, it is rational to look into the applicability of the data we have today.

A update of botanical drug development in the United States: Status of applications

Planta Medica ◽  
2015 ◽  
Vol 81 (11) ◽  
Author(s):  
KM Wu ◽  
C Wu ◽  
J Dou ◽  
H Ghantous ◽  
S Lee ◽  
...  
Keyword(s):  
United States ◽  
Drug Development ◽  
The United States ◽  
Botanical Drug
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