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

Role of mitochondria in progression of cancer: a semi-quantitative study

Mitochondria have been an area of scientific study for more than 100 years. It was in early 20th century that Otto Warburg first described differences in the mitochondria of tumors v/s normal cells. It was observed that tumor cells have increased rate of aerobic glycolysis compared with normal cells. The study was carried out in patients diagnosed as premalignant and malignant conditions which had three objectives that is to demonstrate the presence or absence of mitochondria in cytological smears, in order to perform a semi-quantitative analysis on the number of mitochondria and to identify the difference in distribution mitochondria if any. The study was carried out in the Department of Oral and Maxillofacial Pathology of S.P.D.C., Sawangi, Wardha with consent from patients and approval from the institutional ethical committee. 20 patients each diagnosed clinically and histo-pathologically with OSCC and Premalignant conditions or lesions respectively were selected for the purpose of the study. 20 subjects who had come for routine endodontic treatment were taken as control group for the purpose of the study. It was observed that there was even distribution of mitochondria throughout the cytoplasm in smear that had been taken from normal mucosa which appeared sharply defined whereas in premalignant mitochondria were located in the perinuclear zone and 10% in the peripheral zone and in malignant conditions distribution was sparse in the perinuclear area and appeared ill-defined

Cost-effectiveness analysis of secukinumab versus other biologics and apremilast in the treatment of active Psoriatic arthritis : a Finnish perspective

ObjectiveTo study cost-effectiveness of an interleukin (IL)-17A inhibitor secukinumab, with other biologics and apremilast in patients with Psoriatic arthritis (PsA) from payer perspective in Finland.MethodsIn this semi-Markov model, subcutaneous (SC) secukinumab was compared with SC treatments etanercept and its biosimilar, certolizumab pegol, adalimumab and its biosimilar, golimumab, ustekinumab, intravenous (IV) treatment infliximab, as well as oral non-biologic apremilast. Patients without prior exposure (naive) to biologics and without moderate to severe psoriasis were considered for secukinumab 150mg group. Secukinumab 300mg group included naive patients with moderate to severe psoriasis and all patients with prior biologic exposure. The PsA Response Criteria (PsARC) at 12-week was primary criteria for treatment response. Other clinical as well as cost related model inputs were derived from relevant clinical trials as well as Finnish publications. The key model outcomes were quality-adjusted life years and incremental cost-effectiveness ratio. An annual 3% discount rate was applied to all future costs and benefits. Model input variations were assessed through sensitivity analyses and alternative scenario analyses.ResultsFor a lifetime horizon (60years), secukinumab 150mg dominated all branded SC biologics and apremilast with highest QALY of 8.01 and lowest lifetime cost of Euro187,776, while it was cost-effective against IV infliximab among biologic-naive patients without moderate to severe psoriasis. Secukinumab 300mg was cost-effective against all branded SC biologics and apremilast and dominated IV infliximab among biologic-naive patients with moderate to severe psoriasis, while it was cost-effective in biologic experienced patients. With the one-way sensitivity analysis, PsARC response, drug acquisition cost, and health assessment questionnaire score were the most important parameters affecting the outcomes. Across all treatment groups, patients on secukinumab were most likely to achieve highest net monetary benefit than other competitors in probabilistic sensitivity analysis. With alternative scenario analysis, results largely remained unchanged.ConclusionsSecukinumab is a cost-effective treatment for PsA patients from a Finnish payer's perspective.Peer reviewe

Myxoid Chondrosarcoma of Maxilla in a Pediatric Patient: A Rare Case Report

Myxoid variant of chondrosarcoma is an uncommon potentially lethal malignant tumor which is even rare in pediatric age group. In the present paper, we report one such case of intermediate grade myxoid chondrosarcoma of left side of maxilla in a 12-year-old girl. The present case had a firm, painless, and lobulated growth in premolar-molar region which was associated with bicortical expansion. Maxillofacial imaging showed ill-defined radiolucency with displaced maxillary molars. Osteolytic changes were evident with the alveolus and walls of maxillary sinus. Owing to the age of the patient, surgical excision was selected as the modality of management followed by postoperative radiotherapy. This report encompasses the entire gamut of clinicopathological, radiological, and treatment modalities employed for chondrosarcoma

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

Study of Structural Design Concepts for small-scale Aircraft using low-cost Manufacturing Techniques

Research on structural design concepts and structural optimization for aerospace vehicles typically focuses on large vehicles produced by major aerospace companies. However, the results are aoften of only limited benefit for SMEs or startup companies, that are developing drones or small-scale flight demonstrastors. Such companies typically lack the sophisticated analysis/optimization software and manufacturing capabilities that are available at larger companies form producing high-performance structural components. Moreover, SMEs and startups typically operate under a higher budget and timing pressure. In consequence, the optima for low-weight/low-cost manufactoring of large vehicle structures produced by SMEs/startups. Therefore, this thesis will investigate diffenrent structural design and material concepts for small-scalre vehicles when usind simple manufactoring techniques. This covers analysis and simulation, as well as manufacturing and mechanical testing of selected and representative structural components. The figuers of merit of this trade-off study are to be investigated on a quantitative basis, and include structural mass for a given load, manufacturing costs and manufacturing time. The focus of the study is placed on flight vehicles with low aspect-ratios, a representative of high-performance aircraft geometrics, and glass/carbon fibre reinforced composite materials

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

Neurofibroma of the maxillary antrum: A rare case

Neurofibromas are benign tumors of peripheral nerve tissue, frequently associated with neurofibromatosis type 1. Their isolated occurrence in the maxillary antrum is rare, with only 6 cases described in the English literature to the best of our knowledge. Primary neurogenic tumors in the maxillary sinus are unusual entities. The majority of the reported cases that have dealt with neurilemmomas and isolated neurofibromas are extremely rare. Here, a case of neurofibroma of the maxillary sinus. We present the case of a 60-year-old female patient with the chief complain of growth in the upper right back region of the jaw, which was preceded by exfoliation of teeth in the same region 1 month back

Tuning of Dielectric Properties of Polymers by Composite Formation: The Effect of Inorganic Fillers Addition

Polymer blend or composite, which is a combination of two or more polymers and fillers such as semiconductors, metals, metal oxides, salts and ceramics, are a synthesized product facilitating improved, augmented or customized properties, and have widespread applications for the achievement of functional materials. Polymer materials with embedded inorganic fillers are significantly appealing for challenging and outstanding electric, dielectric, optical and mechanical applications involving magnetic features. In particular, a polymer matrix exhibiting large values of dielectric constant (ε′) with suitable thermal stability and low dielectric constant values of polymer blend, having lesser thermal stability, together offer significant advantages in electronic packaging and other such applications in different fields. In this review paper, we focused on the key factors affecting the dielectric properties and its strength in thin film of inorganic materials loaded poly methyl meth acrylate (PMMA) based polymer blend (single phase) or composites (multiple phase), and its consequences at low and high frequencies are explored. A wide range of different types of PMMA based polymer blends or composites, which are doped with different fillers, have been synthesized with specific tailoring of their dielectric behavior and properties. A few of them are discussed in this manuscript, with their different preparation techniques, and exploring new ideas for modified materials