Topical corticosteroid therapy: clobetasol propionate 0.025%

Topical corticosteroids have been the cornerstone of treatment over the last six decades for various dermatoses characterized by dry, scaly, crusted, or erythematous skin as well as those associated with inflammation and pruritus. The potency of a topical steroid depends on the specific molecule, the amount of drug reaching the target, absorption through the skin (0.25%–3%), and the formulation. Clobetasol propionate (CP) 0.025% cream formulation is a potent, fifth-generation topical corticosteroid. It is approved by the United States Food and Drug Administration to be applied twice daily for the treatment of moderate-to–severe psoriasis in adults. This case series covers the clinical experience of various dermatologists, including their expert opinion on the safety and efficacy of ImpoyzTM (CP) cream 0.025% in different skin disorders

An Overview on Comparative Study of Registration Requirements for Generics in US, Canada and Europe

Generic Drug Product approval is most stringent and crucial process for company with different rules and regulation in different country. For the registration of the product company has to follow regulatory rules and requirement of country specific agency. Company should apply product marketing authorization as per norms of country requirements and should manage life cycle of that product throughout market. Need to understand and describe the various regulatory requirements for the generic drug approval process and comparison of regulated country. To understand the technical requirements required to market medicines in regulated pharmaceutical market. To evaluate similarities and differences within regulated market of U.S, Canada, and Europe. To understand and evaluate differences of post approval Changes within regulated market

Does Prolonged Length of Stay in the Emergency Department Affect Outcome for Stroke Patients?

Introduction: Conflicting data exist regarding the association between the length of stay (LOS) of critically ill patients in the emergency department (ED) and their subsequent outcome. However, such patients are an overall heterogeneous group, and we therefore sought to study the association between EDLOS and outcomes in a specific subgroup of critically ill patients, namely those with acute ischemic stroke/transient ischemic attack (AIS/TIA).Methods: This was a retrospective review of adult patients with a discharge diagnosis of AIS/TIA presenting to an ED between July 2009 and February 2010. We collected demographics, EDLOS, arrival stroke severity (National Institutes of Health Stroke Scale - NIHSS), intravenous tissue plasminogen activator (IV tPA) use, functional outcome at discharge, discharge destination and hospital-LOS. We analyzed relationship between EDLOS, outcomes and discharge destination aftercontrolling for confounders.Results: 190 patients were included in the cohort. Median EDLOS was 332 minutes (Inter-Quartile Range -IQR: 250.3–557.8). There was a significant inverse linear association between EDLOS and hospital-LOS (p¼0.049). Patients who received IV tPA had a shorter median EDLOS (238 minutes, IQR: 194–299) than patients who did not (median: 387 minutes, IQR: 285–588 minutes; p,0.0001). There was no significant association between EDLOS and poor outcome (p¼0.40), discharge destination (p¼0.20), or death (p¼0.44). This remained true even after controlling for IV tPA use, NIHSS and hospital-LOS; and did not change even when analysis was restricted to AIS patients alone.Conclusion: There was no significant association between prolonged EDLOS and outcome for AIS/ TIA patients at our institution. We therefore suggest that EDLOS alone is an insufficient indicator of stroke care in the ED, and that the ED can provide appropriate acute care for AIS/TIA patients. [West J Emerg Med. 2014;15(3):267–275.

Does Prolonged Length of Stay in the Emergency Department Affect Outcome for Stroke Patients?

Introduction: Conflicting data exist regarding the association between the length of stay (LOS) of critically ill patients in the emergency department (ED) and their subsequent outcome. However, such patients are an overall heterogeneous group, and we therefore sought to study the association between EDLOS and outcomes in a specific subgroup of critically ill patients, namely those with acute ischemic stroke/transient ischemic attack (AIS/TIA).Methods: This was a retrospective review of adult patients with a discharge diagnosis of AIS/TIA presenting to an ED between July 2009 and February 2010. We collected demographics, EDLOS, arrival stroke severity (National Institutes of Health Stroke Scale - NIHSS), intravenous tissue plasminogen activator (IV tPA) use, functional outcome at discharge, discharge destination and hospital-LOS. We analyzed relationship between EDLOS, outcomes and discharge destination aftercontrolling for confounders.Results: 190 patients were included in the cohort. Median EDLOS was 332 minutes (Inter-Quartile Range -IQR: 250.3–557.8). There was a significant inverse linear association between EDLOS and hospital-LOS (p¼0.049). Patients who received IV tPA had a shorter median EDLOS (238 minutes, IQR: 194–299) than patients who did not (median: 387 minutes, IQR: 285–588 minutes; p,0.0001). There was no significant association between EDLOS and poor outcome (p¼0.40), discharge destination (p¼0.20), or death (p¼0.44). This remained true even after controlling for IV tPA use, NIHSS and hospital-LOS; and did not change even when analysis was restricted to AIS patients alone.Conclusion: There was no significant association between prolonged EDLOS and outcome for AIS/ TIA patients at our institution. We therefore suggest that EDLOS alone is an insufficient indicator of stroke care in the ED, and that the ED can provide appropriate acute care for AIS/TIA patients. [West J Emerg Med. 2014;15(3):267–275.

6-minute walk test as a measure of disease progression and fatigability in a cohort of individuals with RYR1-related myopathies

Abstract Background RYR1-related Myopathies (RYR1-RM) comprise a group of rare neuromuscular diseases (NMDs) occurring in approximately 1/90000 people in the US pediatric population. RYR1-RM result from pathogenic mutations in the ryanodine receptor isoform-1 (RYR1) gene where consequent RyR1 protein calcium dysregulation leads to impaired excitation-contraction coupling, oxidative and nitrosative stress, and mitochondrial depletion. These physiological deficits perpetuate RyR1 dysfunction causing further muscle injury, muscle weakness, and muscle fatigue. Muscle weakness and fatigue are two primary complaints in patients with RYR1-RM and are major symptoms that limit the ability of individuals to perform activities of daily living. The six-minute walk test (6MWT) is an endurance test with high reliability and validity used to measure walking capacity, disease progression, and more recently, fatigability in NMDs with limited results in RYR1-RM. Therefore, the purpose of our study is to objectively assess disease progression and fatigability in RYR1-RM affected individuals using the 6MWT. We hypothesized that 6MWT distance and fatigability would not change significantly between 0 and 6-month visits in RYR1-RM patients, given the clinically reported stable or slowly progressive nature of the disease. We also hypothesized participants would show fatigability during the 6MWT, given muscle weakness and fatigue are the two primary complaints of affected individuals. Results As expected, paired t-test analyses revealed no significant difference between total distance traveled (p = .608) or percent change in speed (p = .141) at 0-months compared with the 6-month visit. Fatigability was observed given the decline in speed between the first and last minute of the 6MWT at the 6-month time point (p ≤ .0005,). Although this decline was not significant at baseline, a significant decline in speed from the 1st minute did occur at minutes 2, 3, and 4 during the baseline visit. Conclusion In this RYR1-RM cohort, the 6MWT showed disease stability over a 6-month period but revealed fatigability during the test. Given these results, the 6MWT may be a promising endpoint for evaluating fatigability and therapeutic efficacy in the 6-month treatment phase of our current n-acetylcysteine trial in this population. Improvement post intervention could be attributed to the intervention rather than variability in disease progression. Trial Registration Clinical Trials.gov, NCT02362425, Registered 13 February 2015-Prospectively registered