Discovery and Development of Antibacterial Agents: Fortuitous and Designed

2021 ◽  
Vol 22 ◽  
Author(s):  
Ravleen Kaur ◽  
Pooja Rani ◽  
Atanas G Atanasov ◽  
Qushmua Alzahrani ◽  
Reena Gupta ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Antibacterial Agents ◽  
Public Health Issue ◽  
Antibacterial Drug ◽  
Phase 3 ◽  
New Agents ◽  
Critical Elements ◽  
Significant Public Health ◽  
Conventional Antibiotics ◽  
Antibacterial Drug Resistance

Abstract: Today, antibacterial drug resistance has turned into a significant public health issue. Repeated intake, suboptimal and/or unnecessary use of antibiotics, and, additionally, the transfer of resistance genes are the critical elements that make microorganisms resistant to conventional antibiotics. A substantial number of antibacterials that were successfully utilized earlier for prophylaxis and therapeutic purposes have been rendered inadequate due to this phenomenon. Therefore, the exploration of new molecules has become a continuous endeavour. Many such molecules are at various stages of investigation. A surprisingly high number of new molecules are currently in the stage of phase 3 clinical trials. A few new agents have been commercialized in the last decade. These include solithromycin, plazomicin, lefamulin, omadacycline, eravacycline, delafloxacin, zabofloxacin, finafloxacin, nemonoxacin, gepotidacin, zoliflodacin, cefiderocol, BAL30072, avycaz, zerbaxa, vabomere, relebactam, tedizolid, cadazolid, sutezolid, triclosan and afabiacin. This article aims to review the investigational and recently approved antibacterials with a focus on their structure, mechanisms of action/resistance, and spectrum of activity. Delving deep, their success or otherwise in various phases of clinical trials is also discussed while attributing the same to various causal factors.

scholarly journals Anti-VEGF for the Management of Diabetic Macular Edema

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Francisco Rosa Stefanini ◽  
Emmerson Badaró ◽  
Paulo Falabella ◽  
Michael Koss ◽  
Michel Eid Farah ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Macular Edema ◽  
Diabetic Macular Edema ◽  
Vision Loss ◽  
Cochrane Library ◽  
Public Health Issue ◽  
Anti Vegf ◽  
Significant Public Health ◽  
Endothelial Growth Factor

Diabetic retinopathy (DR) is an important cause of vision loss around the world, being the leading cause in the population between 20 and 60 years old. Among patients with DR, diabetic macular edema (DME) is the most frequent cause of vision impairment and represents a significant public health issue. Macular photocoagulation has been the standard treatment for this condition reducing the risk of moderate visual loss by approximately 50%. The role of vascular endothelial growth factor (VEGF) in DR and DME pathogenesis has been demonstrated in recent studies. This review addresses and summarizes data from the clinical trials that investigated anti-VEGF for the management of DME and evaluates their impact on clinical practice. The literature searches were conducted between August and October 2013 in PubMed and Cochrane Library with no date restrictions and went through the most relevant studies onpegaptanib,ranibizumab,bevacizumab, andafliberceptfor the management of DME. The efficacy and safety of intravitreal anti-VEGF as therapy for DME have recently been proved by various clinical trials providing significantly positive visual and anatomical results. Regarding clinical practice, those outcomes have placed intravitreal injection of anti-VEGF as an option that must be considered for the treatment of DME.

Identifying changes in trends in the age standardized incidence of melanoma in Australia

2019 ◽  
Vol 3 (4) ◽  
pp. 250-252 ◽  
Author(s):  
David M Hille
Keyword(s):  
Public Health ◽  
Linear Regression ◽  
Iterative Process ◽  
Linear Trend ◽  
Piecewise Linear ◽  
Health Issue ◽  
Public Health Issue ◽  
Piecewise Linear Regression ◽  
Significant Public Health ◽  
Males And Females

ObjectiveTo identify changes in the linear trend of the age-standardized incidence of melanoma in Australia for all persons, males, and females. MethodsA two-piece piecewise linear regression was fitted to the data. The piecewise breakpoint varied through an iterative process to determine the model that best fits the data.ResultsStatistically significant changes in the trendof the age-standardized incidence of melanoma in Australia were found for all persons, males, and females. The optimal breakpoint for all persons and males was at 1998. For females, the optimal breakpoint was at 2005. The trend after these breakpoints was flatter than prior to the breakpoints, but still positive.ConclusionMelanoma is a significant public health issue in Australia. Overall incidence continues to increase. However, the rate at which the incidence is increasing appears to be decreasing.

Efficacy of Certolizumab Pegol for Psoriasis of the Head and Neck in Two Phase 3 Clinical Trials: CIMPASI-1 and CIMPASI-2

2019 ◽  
Vol 3 ◽  
pp. S40
Author(s):  
P Van de Kerkhof ◽  
A Pinter ◽  
M Boehnlein ◽  
S Kavanagh ◽  
J.J. Crowley
Keyword(s):  
Clinical Trials ◽  
Head And Neck ◽  
Certolizumab Pegol ◽  
Phase 3 ◽  
Two Phase

Abstract not available.

Assessing Acute St-Elevation Myocardial Infarction With Prognostic Significance Of The Hyponatramia

2020 ◽  
Vol 11 (3) ◽  
pp. 3251-3260
Author(s):  
Makrand B Mane
Keyword(s):  
Myocardial Infarction ◽  
Ejection Fraction ◽  
Tertiary Care ◽  
Prognostic Significance ◽  
Care Facility ◽  
Early Death ◽  
Public Health Issue ◽  
Care Hospital ◽  
Tertiary Care Facility ◽  
Significant Public Health

Acute Myocardial Infarction (AMI) has become a significant public health issue in developed and developing nations, following extensive diagnostic and management research over recent decades. The study intended to research the prognostic values of inexplicable Hyponatremia in patients with severe STelevation of myocardial infarction, in 100 consecutive patients admitted to Tertiary care hospital. In the analysis, identified patients on admission were diagnosed with or produced Hyponatremia within 72 hours—a lower ejection fraction than those with usual amounts of sodium. The research aimed to evaluate the prognosis significance of Hyponatremia for the estimation of early death in acute ST-elevated myocardial infarction. One hundred straight patients admitted in the Coronary Centre Tertiary Care Facility with severe STelevated myocardial infarction were studied. The data of the study on various risk factors in association with the development of Hyponatremia like as age, sex, use of tobacco, diabetes, hypertension, ejection fraction etc. were analyzed. Thus, the researchers reported that in patients diagnosed with severe ST section escalation, Hyponatremia showed the initial emergence of hyponatremia myocardial infarctions. This condition correlates with the severity of LV dysfunction (in term of LVEF) and can be considered as an individual early death indicator as well as a prediction exacerbates with hyponatremia frequency.

Clinical Drug Development for the Treatment of Pulmonary Arterial Hypertension: Collaboration With the Pharmaceutical Industry and Regulatory Agencies

2010 ◽  
Vol 9 (4) ◽  
pp. 214-219
Author(s):  
Robyn J. Barst
Keyword(s):  
Clinical Trials ◽  
Pulmonary Arterial Hypertension ◽  
Drug Development ◽  
Phase 1 ◽  
Preclinical Studies ◽  
Phase 2 ◽  
Phase 3 ◽  
Preclinical Testing ◽  
New Drug ◽  
Pulmonary Arterial

Drug development is the entire process of introducing a new drug to the market. It involves drug discovery, screening, preclinical testing, an Investigational New Drug (IND) application in the US or a Clinical Trial Application (CTA) in the EU, phase 1–3 clinical trials, a New Drug Application (NDA), Food and Drug Administration (FDA) review and approval, and postapproval studies required for continuing safety evaluation. Preclinical testing assesses safety and biologic activity, phase 1 determines safety and dosage, phase 2 evaluates efficacy and side effects, and phase 3 confirms efficacy and monitors adverse effects in a larger number of patients. Postapproval studies provide additional postmarketing data. On average, it takes 15 years from preclinical studies to regulatory approval by the FDA: about 3.5–6.5 years for preclinical, 1–1.5 years for phase 1, 2 years for phase 2, 3–3.5 years for phase 3, and 1.5–2.5 years for filing the NDA and completing the FDA review process. Of approximately 5000 compounds evaluated in preclinical studies, about 5 compounds enter clinical trials, and 1 compound is approved (Tufts Center for the Study of Drug Development, 2011). Most drug development programs include approximately 35–40 phase 1 studies, 15 phase 2 studies, and 3–5 pivotal trials with more than 5000 patients enrolled. Thus, to produce safe and effective drugs in a regulated environment is a highly complex process. Against this backdrop, what is the best way to develop drugs for pulmonary arterial hypertension (PAH), an orphan disease often rapidly fatal within several years of diagnosis and in which spontaneous regression does not occur?

New Anti-VEGF Drugs in Ophthalmology

2020 ◽  
Vol 21 (12) ◽  
pp. 1194-1200
Author(s):  
Claudio Campa
Keyword(s):  
Clinical Trials ◽  
Delivery System ◽  
Clinical Development ◽  
Advanced Stage ◽  
Phase 3 ◽  
Anti Vegf

: This review focuses on 5 new anti-VEGF drugs in the advanced stage of clinical development (i.e., phase 3): conbercept, brolucizumab, port delivery system with ranibizumab, abicipar pegol and faricimab. : Results of clinical trials and the advantages of each drug compared to the available molecules are discussed in detail.

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