Incurred sample reanalysis evaluation and impact on drug preclinical and clinical development

2014 ◽  
pp. 134-147
Author(s):  
Stephanie Pasas-Farmer ◽  
Zhongping (John) Lin
Keyword(s):  
Clinical Development ◽  
Incurred Sample Reanalysis

Evaluation of correlation between bioanalytical methods

Bioanalysis ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 419-426 ◽  
Author(s):  
Carol R Gleason ◽  
Qin C Ji ◽  
Enaksha R Wickremsinhe
Keyword(s):  
Bioanalytical Methods ◽  
Clinical Development ◽  
Acceptance Criterion ◽  
Incurred Sample Reanalysis ◽  
Correlative Studies ◽  
The Relationship

Bioanalytical methods evolve throughout clinical development timelines, resulting in the need for establishing equivalency or correlation between different methods to enable comparison of data across different studies. This is accomplished by the conduct of cross validations and correlative studies to compare and describe the relationship. The incurred sample reanalysis acceptance criterion seems to be adopted universally for cross validations and correlative studies; however, this does not identify any trends or biases between the two methods (datasets) being compared. Presented here are graphing approaches suitable for comparing two methods and describing equivalence or correlation. This article aims to generate awareness on graphing techniques that can be adopted during cross validations and correlative studies.

COVID-19 must catalyse changes to clinical development

2020 ◽  
Vol 19 (10) ◽  
pp. 653-654
Author(s):  
Rod MacKenzie ◽  
Peter Honig ◽  
Judy Sewards ◽  
Robert Goodwin ◽  
Marie-Pierre Hellio
Keyword(s):  
Clinical Development

Curcumin: New trends in the formulative and clinical development

Planta Medica ◽  
2014 ◽  
Vol 80 (10) ◽  
Author(s):  
P Morazzoni ◽  
A Riva ◽  
M Ronchi ◽  
G Petrangolini ◽  
W Cabri
Keyword(s):  
Clinical Development

Sending out Biased Signals: an Appropriate Proposition for Pain?

2019 ◽  
Vol 32 (2) ◽  
pp. 108-110 ◽  
Author(s):  
E. Besserer-Offroy ◽  
P. Sarret
Keyword(s):  
Side Effects ◽  
Acute Pain ◽  
Gold Standard ◽  
Pain Treatment ◽  
Opioid Analgesics ◽  
Mu Opioid Receptor ◽  
Clinical Development ◽  
Mu Opioid ◽  
Development Stages ◽  
The Past

In the past few years, several biased ligands acting at the mu-opioid receptor were reported in the literature. These agonists are aimed at reducing pain while having fewer side effects than morphine, the gold standard of opioid analgesics. In this mini-review, we describe and discuss the recent advances in mu-biased ligands actually in preclinical and clinical development stages, including the latest U.S. Food and Drug Administration review of oliceridine, a biased mu-agonist for moderate to severe acute pain treatment developed by the company Trevena.

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