Pediatric Clinical Pharmacology in Regulatory and Drug Development Sciences: Lessons Learned and the Path Forward

2013 ◽  
pp. 271-280
Author(s):  
Gilbert J. Burckart ◽  
Jeremiah D. Momper
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
Lessons Learned ◽  
Pediatric Clinical Pharmacology

Chronic Cannabis Users: A New Special Population to Consider for Drug Development

2021 ◽  
Vol 16 ◽  
Author(s):  
Gina Pastino ◽  
Diana Shuster
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
Cannabis User ◽  
Special Population ◽  
Safety And Efficacy ◽  
New Drug ◽  
Metabolic Interactions ◽  
Widespread Availability ◽  
Baseline Characteristics ◽  
Efficacy Profile

The use and acceptance of cannabis, either medically or recreationally, has substantially outpaced the collection of data necessary to evaluate its use in any population. However, the mere widespread availability does not imply the absence of risk or confirmation of efficacy and should not be treated as such. There is enough data to suggest that not only does the potential for pharmacokinetic and metabolic interactions exist, but also that baseline characteristics for a given population could be different in chronic cannabis users. Either or both of these may impact the safety and efficacy profile for any new drug in development. As such, we encourage drug developers to consider that the cannabis user may very well be a special population that warrants its own clinical pharmacology evaluation.

Clinical Pharmacology in Drug Development for Rare Diseases in Neurology: Contributions and Opportunities

2021 ◽  
Author(s):  
Bilal Abuasal ◽  
Mariam A. Ahmed ◽  
Priyank Patel ◽  
Salwa Albusaysi ◽  
Sreedharan Sabarinath ◽  
...  
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
Rare Diseases

CNS Drug Development, Lessons Learned, Part 4

2017 ◽  
Vol 23 (6) ◽  
pp. 425-430 ◽  
Author(s):  
SHELDON H. PRESKORN
Keyword(s):  
Drug Development ◽  
Lessons Learned

Clinical Pharmacology Modeling and Simulation in Drug Development

2021 ◽  
pp. 243-256
Author(s):  
Ann-Charlotte Egnell ◽  
Susanne Johansson ◽  
Chao Chen ◽  
Alienor Berges
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
Modeling And Simulation

Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use

2020 ◽  
Vol 108 (4) ◽  
pp. 710-715
Author(s):  
Rajanikanth Madabushi ◽  
Elimika Pfuma Fletcher ◽  
Jeffry Florian ◽  
Lauren Milligan ◽  
Anuradha Ramamoorthy ◽  
...  
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
The Impact ◽  
Development Regulation

Orphan drug development: the increasing role of clinical pharmacology

2019 ◽  
Vol 46 (5) ◽  
pp. 395-409 ◽  
Author(s):  
Mariam A. Ahmed ◽  
Malek Okour ◽  
Richard Brundage ◽  
Reena V. Kartha
Keyword(s):  
Clinical Pharmacology ◽  
Drug Development ◽  
Orphan Drug ◽  
Orphan Drug Development
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