Unraveling heterogeneity of the clinical pharmacogenomic guidelines in oncology practice among major regulatory bodies

2020 ◽  
Vol 21 (17) ◽  
pp. 1247-1264
Author(s):  
Mohamed Nagy ◽  
Mohamed Attya ◽  
George P Patrinos
Keyword(s):  
Genetic Information ◽  
Medication Use ◽  
Clinical Settings ◽  
National Network ◽  
The Us ◽  
Regulatory Bodies ◽  
Medication Efficacy ◽  
Us Fda ◽  
Highly Correlated ◽  
Oncology Practice

Pharmacogenomics (PGx) implementation in clinical practice is steadily increasing. PGx uses genetic information to personalize medication use, which increases medication efficacy and decreases side effects. The availability of clinical PGx guidelines is essential for its implementation in clinical settings. Currently, there are few organizations/associations responsible for releasing those guidelines, including the Clinical Pharmacogenetics Implementation Consortium, Dutch Pharmacogenetics Working Group, the Canadian Pharmacogenomics Network for Drug Safety and the French National Network of Pharmacogenetics. According to the US FDA, oncology medications are highly correlated to PGx biomarkers. Therefore, summarizing the PGx guidelines for oncology drugs will positively impact the clinical decisions for cancer patients. This review aims to scrutinize side-by-side available clinical PGx guidelines in oncology.

scholarly journals Accessing the Pattern Prescribed for Pregnant Women for Both in and outpatient in Obstetrics and Gynecology Department

2020 ◽  
Vol 11 (SPL4) ◽  
pp. 344-349
Author(s):  
Syam Mohan Rao M ◽  
Ramanarao ◽  
Om Prakash Yadav ◽  
Narayana Reddy
Keyword(s):  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Medication Use ◽  
Care Hospital ◽  
Cross Sectional ◽  
Medication Treatment ◽  
The Us ◽  
Class B ◽  
Solution Design ◽  
Us Fda

A Prospective cross-sectional examination was completed so as to survey the solution design in pregnant ladies. Going to Antenatal in and Outpatient Department of a Tertiary Care Hospital. A cross-sectional investigation was led by looking into the antenatal consideration In & outpatient office case papers of 230 irregular pregnant ladies. The remedy design was surveyed and the medications were arranged dependent on the US FDA Risk Classification. Out of 230 solutions, just 177 remedies had medicates other than iron, folic corrosive and calcium lactate. In this examination the majority of the medications endorsed falls under class B (26.6%), a reasonable number of medications falls under classification A (16.60%) and C (16.60%) and a couple of medications fall under classification D (6.66%). No medications having a place with class X were recommended. The current examination uncovers that the medication use during pregnancy in and around Bapatla area was insignificant and the majority of the medications were recommended by their conventional names. Recommending by nonexclusive name is known to decrease the expense of medication treatment, defended drug treatment and maintains a strategic distance from disarray.

Regulatory decisions from the US FDA

2001 ◽  
Vol &NA; (1272) ◽  
pp. 22
Author(s):  
&NA;
Keyword(s):  
The Us ◽  
Us Fda ◽  
Regulatory Decisions

scholarly journals Ravulizumab: a novel C5 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria

2019 ◽  
Vol 10 ◽  
pp. 204062071987472 ◽  
Author(s):  
Robert M. Stern ◽  
Nathan T. Connell
Keyword(s):  
Paroxysmal Nocturnal Hemoglobinuria ◽  
Bone Marrow Failure ◽  
Phase Iii ◽  
The European Union ◽  
Regulatory Review ◽  
Dosing Schedule ◽  
The Us ◽  
United States Food ◽  
States Food ◽  
Us Fda

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare stem cell disorder characterized by hemolytic anemia, bone marrow failure, and thrombosis. Until recently, the complement inhibitor, eculizumab, was the only United States Food and Drug Administration (US FDA)-approved therapy for the treatment of PNH. Although effective, eculizumab requires a frequent dosing schedule that can be burdensome for some patients and increases the risk of breakthrough intravascular hemolysis. Ravulizumab, an eculizumab-like monoclonal antibody engineered to have a longer half-life, is intended to provide the same benefits as eculizumab but with a more convenient and effective dosing schedule. In two recently published phase III non-inferiority trials, ravulizumab was found to be non-inferior to eculizumab both in efficacy and safety for the treatment of patients with PNH. Based on these results, ravulizumab was approved by the US FDA on 21 December 2018 and is currently under regulatory review in both the European Union and Japan.

scholarly journals Mozobil® (Plerixafor, AMD3100), 10 years after its approval by the US Food and Drug Administration

2019 ◽  
Vol 27 ◽  
pp. 204020661982938 ◽  
Author(s):  
Erik De Clercq
Keyword(s):  
Autologous Transplantation ◽  
Hepatopulmonary Syndrome ◽  
Blood Stream ◽  
Malignant Diseases ◽  
Whim Syndrome ◽  
Natural Ligand ◽  
Cxcr4 Receptor ◽  
The Us ◽  
Us Fda ◽  
Anti Hiv

AMD3100 (plerixafor, Mozobil®) was first identified as an anti-HIV agent specifically active against the T4-lymphotropic HIV strains, as it selectively blocked the CXCR4 receptor. Through interference with the interaction of CXCR4 with its natural ligand, SDF-1 (also named CXCL12), it also mobilized the CD34+stem cells from the bone marrow into the peripheral blood stream. In December 2008, AMD3100 was formally approved by the US FDA for autologous transplantation in patients with Non-Hodgkin’s Lymphoma or multiple myeloma. It may be beneficially used in various other malignant diseases as well as hereditary immunological disorders such as WHIM syndrome, and physiopathological processes such as hepatopulmonary syndrome.

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