Overview of recently approved 505(b)(2) new drug applications (2010-2012): Role of clinical pharmacology

2014 ◽  
Vol 54 (12) ◽  
pp. 1330-1336 ◽  
Author(s):  
Sheetal Agarwal ◽  
Wei Qiu ◽  
Chandrahas Sahajwalla
Keyword(s):  
Clinical Pharmacology ◽  
New Drug

scholarly journals Metabolic Acidosis in Patients with CKD: Epidemiology, Pathogenesis, and Treatment

2021 ◽  
pp. 1-16
Author(s):  
Marcin Adamczak ◽  
Stanisław Surma
Keyword(s):  
Metabolic Acidosis ◽  
Sodium Bicarbonate ◽  
Current Knowledge ◽  
Venous Blood ◽  
The Body ◽  
Hydrogen Ions ◽  
Ckd Progression ◽  
New Drug ◽  
Treatment And Prevention

<b><i>Background:</i></b> Metabolic acidosis in CKD is diagnosed in patients with plasma or venous blood bicarbonate concentration lower than 22 mmol/L. Metabolic acidosis occurs in about 20% of patients with CKD. Metabolic acidosis may lead to dysfunction of many systems and organs as well as CKD progression. Currently, sodium bicarbonate is mainly used for pharmacological treatment of metabolic acidosis in patients with CKD. Veverimer is a new drug dedicated to treatment of metabolic acidosis in patients with CKD. Orally given veverimer binds hydrogen ions in the intestines and subsequently is excreted from the body with feces. Clinical studies have shown that veverimer is effective in increasing serum bicarbonate concentrations in CKD patients with metabolic acidosis. Here, we present review of the epidemiology, pathogenesis, diagnosis, treatment, and prevention of metabolic acidosis in CKD patients. <b><i>Summary:</i></b> Metabolic acidosis is common in patients with CKD and contributes to CKD progression and many complications, which worsen the prognosis in these patients. Currently, sodium bicarbonate is mainly used in metabolic acidosis treatment. The role of the new drug veverimer in the metabolic acidosis therapy needs further studies. <b><i>Key Message:</i></b> The aim of this review article is to summarize the current knowledge concerning the epidemiology, pathogenesis, diagnosis, treatment, and prevention of metabolic acidosis in CKD patients.

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.

scholarly journals 3-Phenylcoumarins as a Privileged Scaffold in Medicinal Chemistry: The Landmarks of the Past Decade

Molecules ◽  
2021 ◽  
Vol 26 (21) ◽  
pp. 6755
Author(s):  
Maria J. Matos ◽  
Eugenio Uriarte ◽  
Lourdes Santana
Keyword(s):  
Medicinal Chemistry ◽  
Review Paper ◽  
Relevant Literature ◽  
Natural Origin ◽  
Drug Candidates ◽  
Heterocyclic Molecules ◽  
The Past ◽  
New Drug ◽  
Privileged Scaffold

3-Phenylcoumarins are a family of heterocyclic molecules that are widely used in both organic and medicinal chemistry. In this overview, research on this scaffold, since 2010, is included and discussed, focusing on aspects related to its natural origin, synthetic procedures and pharmacological applications. This review paper is based on the most relevant literature related to the role of 3-phenylcoumarins in the design of new drug candidates. The references presented in this review have been collected from multiple electronic databases, including SciFinder, Pubmed and Mendeley.

scholarly journals The role of clinical pharmacology in enhanced recovery after surgery protocols: a comprehensive review

2020 ◽  
Vol 52 (2) ◽  
pp. 154-164
Author(s):  
Alan Kaye ◽  
Jordan Renschler ◽  
Kelsey Cramer ◽  
Kendall Klein ◽  
Amanda Granier ◽  
...  
Keyword(s):  
Clinical Pharmacology ◽  
Enhanced Recovery ◽  
Enhanced Recovery After Surgery ◽  
Comprehensive Review

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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