scholarly journals Global Status of Biosimilars and Its Influential Factors

2020 ◽  
Vol 5 (6) ◽  
Author(s):  
Md. Abu Zafor Sadek
Keyword(s):  
Influential Factors ◽  
Related Factors ◽  
Cheap Labor ◽  
Price Cutting ◽  
Global Status ◽  
United States Food ◽  
History Of ◽  
States Food ◽  
Product Pipeline ◽  
Pharmaceutical Benefits Scheme

The history of biosimilars started at European Union (EU) in 2006 with one product; however, currently it has been recognized everywhere in the world and EU have highest 64 biosimilar products. United States Food & Drug Administration (USFDA) was little unadventurous with biosimilars; nevertheless, they approved the first biosimilar 09 years after EU approval and presently they have 28 biosimilars which are playing significant role in price cutting of branded biologics. They also have so many biosimilars in product pipeline. Economically emerging countries especially China & India are very aggressive with biosimilars. In view of easy regulation, cheap labor & other cost related factors they are in little advantageous than the rivalries. Under Pharmaceutical Benefits Scheme Australian government is encouraging biosimilars and they already approved 20 biosimilars. Japan, Korea, Canada, South Africa are also promoting biosimilars. However, it is worth mentioning that in spite of enormous potentiality and rapid growth till to date biosimilar market is insignificant compared to total pharmaceutical market and success of biosimilars will depend on the acceptance by the physicians, treatment cost reduction, trust on manufacturer, proper information, drug substitution, efficacy, safety etc.

scholarly journals Botulinum toxin in the management of chronic migraine: clinical evidence and experience

2016 ◽  
Vol 10 (2) ◽  
pp. 127-135 ◽  
Author(s):  
Claus M Escher ◽  
Lejla Paracka ◽  
Dirk Dressler ◽  
Katja Kollewe
Keyword(s):  
Chronic Migraine ◽  
Botulinum Neurotoxin ◽  
Prophylactic Treatment ◽  
Clinical Evidence ◽  
The United States ◽  
Headache Frequency ◽  
United States Food ◽  
History Of ◽  
States Food ◽  
Review Reports

Chronic migraine (CM) is a severely disabling neurological condition characterized by episodes of pulsating unilateral or bilateral headache. The United States Food and Drug Administration (FDA) approved onabotulinumtoxinA (Botox®) for the prophylactic treatment of CM in 2010. It has been shown that onabotulinumtoxinA is effective in the reduction of headache frequency and severity in patients with CM. Treatment is well tolerated by the patients. This review reports on the history of botulinum neurotoxin (BoNT) in CM and presents the current clinical evidence for the use of onabotulinumtoxinA in the treatment of CM.

History of the United States Food Administration, 1917-1919

1942 ◽  
Vol 29 (1) ◽  
pp. 116
Author(s):  
J. P. Bretz ◽  
William C. Mullendore ◽  
Herbert Hoover
Keyword(s):  
United States ◽  
The United States ◽  
United States Food ◽  
History Of ◽  
States Food

History of the United States Food Administration, 1917-1919.

1942 ◽  
Vol 6 (2) ◽  
pp. 114
Author(s):  
Forrest Wilson ◽  
William Clinton Mullendore ◽  
Herbert Hoover ◽  
Ralph Haswell Lutz
Keyword(s):  
United States ◽  
The United States ◽  
United States Food ◽  
History Of ◽  
States Food

Transcatheter pulmonary valve insertion, expanded use (beyond large conduits from the right ventricle to pulmonary artery), and future directions

2014 ◽  
Vol 24 (6) ◽  
pp. 1095-1100 ◽  
Author(s):  
Jeremy M. Ringewald ◽  
Elsa J. Suh
Keyword(s):  
Pulmonary Valve ◽  
Right Ventricular Outflow Tract ◽  
Interventional Cardiology ◽  
Ventricular Outflow Tract ◽  
Future Directions ◽  
United States Food ◽  
History Of ◽  
States Food ◽  
The Right

AbstractTranscatheter pulmonary valve insertion is the most important advance in congenital interventional cardiology since atrial septal defect devices became commonly available 15 years ago. It has changed the way we look at a number of diverse diagnoses and changes how we plan, diagnose, operate, and follow-up patients. It has changed how we counsel families expecting a child that may benefit from it. Expanded use of the Melody® valve, outside its United States Food and Drug Administration approved indications, has helped numerous additional patients. The use of transcatheter pulmonary valve insertion in selected patients following surgical Gore-tex® bileaflet in valve right ventricular outflow tract reconstruction and those with a history of prior small homograft conduits will be discussed.

Empiric Management of Cyanide Toxicity Associated with Smoke Inhalation

2011 ◽  
Vol 26 (5) ◽  
pp. 374-382 ◽  
Author(s):  
Daniel J. O’Brien ◽  
Donald W. Walsh ◽  
Colleen M. Terriff ◽  
Alan H. Hall
Keyword(s):  
United States ◽  
Unintentional Injury ◽  
The United States ◽  
Smoke Inhalation ◽  
Cyanide Toxicity ◽  
United States Food ◽  
History Of ◽  
States Food ◽  
Enclosed Space ◽  
Fire Scene

AbstractEnclosed-space smoke inhalation is the fifth most common cause of all unintentional injury deaths in the United States. Increasingly, cyanide has been recognized as a significant toxicant in many cases of smoke inhalation. However, it cannot be emergently verified. Failure to recognize the possibility of cyanide toxicity may result in inadequate treatment. Findings suggestive cyanide toxicity include: (1) a history of an enclosed-space fire scene in which smoke inhalation was likely; (2) the presence of oropharyngeal soot or carbonaceous expectorations; (3) any alteration of the level of consciousness, and particularly, otherwise inexplicable hypotension (systolic blood pressure ≤90 mmHg in adults). Prehospital studies have demonstrated the feasibility and safety of empiric treatment with hydroxocobalamin for patients with suspected smoke inhalation cyanide toxicity. Although United States Food and Drug Administration (FDA)-approved since 2006, the lack of efficacy data has stymied the routine use of this potentially lifesaving antidote. Based on a literature review and on-site observation of the Paris Fire Brigade, emergency management protocols to guide empiric and early hydroxocobalamin administration in smoke inhalation victims with high-risk presentations are proposed.

PREVALENCE AND RELATED FACTORS OF POSTNATAL DEPRESSION IN HIV INFECTED WOMEN

2014 ◽  
pp. 140-152
Author(s):  
Manh Hoan Nguyen ◽  
Ngoc Thanh Cao
Keyword(s):  
Regression Analysis ◽  
Postpartum Depression ◽  
Hiv Infection ◽  
Postnatal Depression ◽  
Past History ◽  
Depression Scale ◽  
Multivariate Regression Analysis ◽  
Related Factors ◽  
History Of ◽  
History Of Depression

Background and Objective: HIV infection is also a cause of postpartum depression, however, in Vietnam, there has not yet the prevalence of postpartum depression in HIV infected women. The objective is to determine prevalence and related factors of postpartum depression in HIV infected women. Materials and Methods: From November 30th, 2012 to March 30th, 2014, a prospective cohort study is done at Dong Nai and Binh Duong province. The sample includes135 HIV infected women and 405 non infected women (ratio 1/3) who accepted to participate to the research. We used “Edinburgh Postnatal Depression Scale (EPDS) as a screening test when women hospitalized for delivery and 1 week, 6weeks postpartum. Mother who score EPDS ≥ 13 are likely to be suffering from depression. We exclude women who have EPDS ≥ 13 since just hospitalize. Data are collected by a structural questionaire. Results: At 6 weeks postpartum, prevalence of depression in HIV infected women is 61%, in the HIV non infected women is 8.7% (p < 0.001). There are statistical significant differences (p<0.05) between two groups for some factors: education, profession, income, past history of depression, child’s health, breast feeding. Logistical regression analysis determine these factors are related with depression: late diagnosis of HIV infection, child infected of HIV, feeling guilty of HIV infected and feeling guilty with their family. Multivariate regression analysis showed 4 factors are related with depression: HIV infection, living in the province, child’s health, past history of depression. Conclusion: Prevalence of postpartum depression in HIV infected women is 61.2%; risk of depression of postnatal HIV infected women is 6.4 times the risk of postnatal HIV non infected women, RR=6.4 (95% CI:4.3 – 9.4). Domestic women have lower risk than immigrant women from other province, RR=0.72 (95% CI:0.5 – 0.9). Past history of depression is a risk factor with RR=1.7 (95% CI:1.02 – 0.9. Women whose child is weak or die, RR=1.7(95% CI:0.9 – 3.1). Keywords: Postpartum depression, HIV-positive postpartum women

Sign in / Sign up

Export Citation Format

Share Document