The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation

The development of biosimilars is growing rapidly, especially in Europe. They are a cost-effective alternative to original biological medicines and can help improve patient access to these therapies. The European Medicines Agency (EMA) has been the first to issue scientific guidelines related to regulatory requirements for the approval of biosimilars. These guidelines have been being updated in line with advances in analytical techniques and growing experience in the clinical use of these drugs. Given the complex nature of biological medicines, they pose a greater potential risk of immunogenicity than nonbiological medicines, and hence warrant special consideration. The risk management plan for biopharmaceuticals (innovator and biosimilar drugs) should be based on strengthening ongoing pharmacovigilance activities, especially in the post-approval period. This paper addresses regulatory issues related to the approval of biosimilars in Europe associated with safety considerations linked to the development and use of these medicines. We also discuss the issues of immunogenicity, interchangeability and traceability of biological medicines.

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Exploring user perceptions of Surgical Tele-clinics during COVID-19

The Physician ◽

10.38192/1.6.3.5 ◽

2020 ◽

Vol 6 (3) ◽

pp. 1-5

Author(s):

Meghana Taggarsi ◽

Subba Rao Kanchustambam

Keyword(s):

Physical Examination ◽

Cost Effective ◽

Management Plan ◽

Outpatient Clinics ◽

User Perceptions ◽

Face To Face ◽

Clinical Consultation ◽

Efficiency And Effectiveness ◽

Cost Effective Alternative ◽

The Uk

ABSTRACT Background and Aims: To assess the user perceptions on efficiency and effectiveness of Tele-clinics during the COVID-19 pandemic. Methods: An audit collected feedback based on questionnaires from surgeons, patients and nurses, conducting/attending tele-clinics after 4 weeks of their initiation in the first surge of COVID-19 in the UK. Results: In this audit, 15 clinicians and 12 patients were opportunistically interviewed. 46% of the clinicians and 83% of the patients agreed that telephonic consultation was convenient, flexible and time-efficient. Two-thirds of clinicians felt that it required less staffing and therefore was cost-effective. Majority of patients (80%) agreed that tele-clinics were efficient, were associated with less stress/ anxiety. Most (86%) surgeons agreed that tele-clinics were limited by the lack of access to a detailed physical examination. Almost half the responses from clinicians, were positive regarding the effectiveness in reaching a diagnosis/ planning management, with a recognition of the potential risk for under or over-investigation. Most (91.6%) patients were satisfied with the way their clinical consultation was addressed. Some patients would still prefer to meet their doctor face-to-face to discuss a final management plan. Conclusions: Our audit provides evidence that Tele-clinics offered an efficient, potentially environmental conscious, cost-effective alternative to physical outpatient clinics, both to clinicians and patients, with recognised limitations.

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2D Color-Intensity Representation of Ultrasonic Thickness Gauge Measurements

Materials Evaluation ◽

10.32548/2020.me-04177 ◽

2020 ◽

pp. 1192-1198

Author(s):

M.S. Mohammad ◽

Tibebe Tesfaye ◽

Kim Ki-Seong

Keyword(s):

Cost Effective ◽

The Other ◽

Thickness Gauge ◽

Color Intensity ◽

Digital Readout ◽

Flat Surfaces ◽

Video Cameras ◽

Wide Range ◽

Cost Effective Alternative ◽

Ultrasonic Thickness

Ultrasonic thickness gauges are easy to operate and reliable, and can be used to measure a wide range of thicknesses and inspect all engineering materials. Supplementing the simple ultrasonic thickness gauges that present results in either a digital readout or as an A-scan with systems that enable correlating the measured values to their positions on the inspected surface to produce a two-dimensional (2D) thickness representation can extend their benefits and provide a cost-effective alternative to expensive advanced C-scan machines. In previous work, the authors introduced a system for the positioning and mapping of the values measured by the ultrasonic thickness gauges and flaw detectors (Tesfaye et al. 2019). The system is an alternative to the systems that use mechanical scanners, encoders, and sophisticated UT machines. It used a camera to record the probe’s movement and a projected laser grid obtained by a laser pattern generator to locate the probe on the inspected surface. In this paper, a novel system is proposed to be applied to flat surfaces, in addition to overcoming the other limitations posed due to the use of the laser projection. The proposed system uses two video cameras, one to monitor the probe’s movement on the inspected surface and the other to capture the corresponding digital readout of the thickness gauge. The acquired images of the probe’s position and thickness gauge readout are processed to plot the measured data in a 2D color-coded map. The system is meant to be simpler and more effective than the previous development.

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Regulatory and sustainability initiatives lead to improved polyaminopolyamide epichlorohydrin (PAE) wet-strength resins and paper products

TAPPI Journal ◽

10.32964/tj17.09.519 ◽

2018 ◽

Vol 17 (09) ◽

pp. 519-532 ◽

Cited By ~ 1

Author(s):

Mark Crisp ◽

Richard Riehle

Keyword(s):

Health And Safety ◽

Cost Effective ◽

Worker Safety ◽

Regulatory Requirements ◽

Wet Strength ◽

The Past ◽

Consumer Safety ◽

Federal Institute ◽

Sustainability Initiatives ◽

The Impact

Polyaminopolyamide-epichlorohydrin (PAE) resins are the predominant commercial products used to manufacture wet-strengthened paper products for grades requiring wet-strength permanence. Since their development in the late 1950s, the first generation (G1) resins have proven to be one of the most cost-effective technologies available to provide wet strength to paper. Throughout the past three decades, regulatory directives and sustainability initiatives from various organizations have driven the development of cleaner and safer PAE resins and paper products. Early efforts in this area focused on improving worker safety and reducing the impact of PAE resins on the environment. These efforts led to the development of resins containing significantly reduced levels of 1,3-dichloro-2-propanol (1,3-DCP) and 3-monochloropropane-1,2-diol (3-MCPD), potentially carcinogenic byproducts formed during the manufacturing process of PAE resins. As the levels of these byproducts decreased, the environmental, health, and safety (EH&S) profile of PAE resins and paper products improved. Recent initiatives from major retailers are focusing on product ingredient transparency and quality, thus encouraging the development of safer product formulations while maintaining performance. PAE resin research over the past 20 years has been directed toward regulatory requirements to improve consumer safety and minimize exposure to potentially carcinogenic materials found in various paper products. One of the best known regulatory requirements is the recommendations of the German Federal Institute for Risk Assessment (BfR), which defines the levels of 1,3-DCP and 3-MCPD that can be extracted by water from various food contact grades of paper. These criteria led to the development of third generation (G3) products that contain very low levels of 1,3-DCP (typically <10 parts per million in the as-received/delivered resin). This paper outlines the PAE resin chemical contributors to adsorbable organic halogens and 3-MCPD in paper and provides recommendations for the use of each PAE resin product generation (G1, G1.5, G2, G2.5, and G3).

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Regulatory Issues in Pakistan Telecommunication

The Pakistan Development Review ◽

10.30541/v37i4iipp.873-882 ◽

1998 ◽

Vol 37 (4II) ◽

pp. 873-882 ◽

Cited By ~ 1

Author(s):

Sarfaraz Khan Quershi

Keyword(s):

National Economy ◽

Cost Effective ◽

Market Forces ◽

Global Trends ◽

Regulatory Issues ◽

Competitive Price ◽

Modern Services ◽

A Company ◽

Telecom Infrastructure

Growth in telecom infrastructure and provision of modern telecom services to consumers at a cost based tariff helps growth of national economy. Modern telecoms serve as the engine of growth of national economy. Following the global trends of liberalisation and deregulation in telecoms monopolies which have thus far been providing inefficient communication at a greedily high tariffs are falling apart. Mergers in telecoms are not for increasing the size of the monopoly but to provide more efficient and cost effective services to the consumers. In Pakistan the erstwhile T&T department played a needful role at its time. Conversion of the department into a corporation and then into a company were steps necessary for following the global trends. Need now is to continue this trend further, eliminate the monopolistic approach by allowing more players in the field thus permitting the market forces to decide the provision of better quality of modern services at competitive price.

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JS777

Alloy Digest ◽

10.31399/asm.ad.ss0377 ◽

1980 ◽

Vol 29 (11) ◽

Keyword(s):

Stainless Steel ◽

Corrosion Resistance ◽

Austenitic Stainless Steel ◽

Cost Effective ◽

Heat Treating ◽

Steel Company ◽

High Alloy ◽

Cost Effective Alternative ◽

Resistance To Stress ◽

Nickel Base

Abstract JS777 is a high-alloy, fully austenitic stainless steel developed for applications where corrosive conditions are too severe for the standard grades of stainless steel. It also provides a cost-effective alternative to more expensive nickel-base and titanium-base alloys. It has relatively high resistance to stress-corrosion cracking and to intergranular corrosion. This datasheet provides information on composition, physical properties, hardness, elasticity, and tensile properties. It also includes information on corrosion resistance as well as forming, heat treating, machining, joining, and surface treatment. Filing Code: SS-377. Producer or source: Jessop Steel Company.

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ANCORSTEEL 4300

Alloy Digest ◽

10.31399/asm.ad.sa0611 ◽

2009 ◽

Vol 58 (11) ◽

Keyword(s):

Fracture Toughness ◽

Physical Properties ◽

Tensile Properties ◽

Cost Effective ◽

Heat Treating ◽

Effective Alternative ◽

Powder Metal ◽

Secondary Processing ◽

Cost Effective Alternative

Abstract Ancorsteel 4300 alloy ferrous powder simulates wrought steel compositions and is a cost-effective alternative to alloys requiring secondary processing. This datasheet provides information on composition, physical properties, hardness, and tensile properties as well as fracture toughness. It also includes information on heat treating and powder metal forms. Filing Code: SA-611. Producer or source: Hoeganaes Corporation.

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Faculty Opinions recommendation of Is elective single embryo transfer a cost-effective alternative to double embryo transfer?

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.1058887.510823 ◽

2007 ◽

Author(s):

Julia Hussein

Keyword(s):

Embryo Transfer ◽

Cost Effective ◽

Single Embryo Transfer ◽

Effective Alternative ◽

Elective Single Embryo Transfer ◽

Cost Effective Alternative ◽

Double Embryo Transfer

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OP0198-HPR A STRUCTURED MODEL FOR OA CARE IN PRIMARY HEALTHCARE IS A COST-EFFECTIVE ALTERNATIVE COMPARED TO USUAL CARE FOR PEOPLE WITH HIP AND KNEE OA

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2021-eular.950 ◽

2021 ◽

Vol 80 (Suppl 1) ◽

pp. 119-120

Author(s):

N. Østerås ◽

E. Aas ◽

T. Moseng ◽

L. Van Bodegom-Vos ◽

K. Dziedzic ◽

...

Keyword(s):

Usual Care ◽

Primary Healthcare ◽

Intervention Group ◽

Cost Effective ◽

Cost Utility ◽

Control Group ◽

Structured Model ◽

Knee Oa ◽

Cost Effective Alternative ◽

The Cost

Background:To improve quality of care for patients with hip and knee osteoarthritis (OA), a structured model for integrated OA care was developed based on international treatment recommendations. A previous analysis of a cluster RCT (cRCT) showed that compared to usual care, the intervention group reported higher quality of care and greater satisfaction with care. Also, more patients were treated according to international guidelines and fulfilled recommendations for physical activity at the 6-month follow-up.Objectives:To assess the cost-utility of a structured model for hip or knee OA care.Methods:A cRCT with stepped-wedge cohort design was conducted in 6 Norwegian municipalities (clusters) in 2015-17. The OA care model was implemented in one cluster at the time by switching from “usual care” to the structured model. The implementation of the model was facilitated by interactive workshops for general practitioners (GPs) and physiotherapists (PTs) with an update on OA treatment recommendations. The GPs explained the OA diagnosis and treatment alternatives, provided pharmacological treatment when appropriate, and suggested referral to physiotherapy. The PT-led patient OA education programme was group-based and lasted 3 hours followed by an 8–12-week individually tailored resistance exercise programme with twice weekly 1-hour supervised group sessions (5–10 patients per PT). An optional 10-hours Healthy Eating Program was available. Participants were ≥45 years with symptomatic hip or knee OA.Costs were measured from the healthcare perspective and collected from several sources. Patients self-reported visits in primary healthcare at 3, 6, 9 and 12 months. Secondary healthcare visits and joint surgery data were extracted from the Norwegian Patient Register. The health outcome, quality-adjusted life-year (QALY), was estimated based on the EQ-5D-5L scores at baseline, 3, 6, 9 and 12 months. The result of the cost-utility analysis was reported using the incremental cost-effectiveness ratio (ICER), defined as the incremental costs relative to incremental QALYs (QALYs gained). Based on Norwegian guidelines, the threshold is €27500. Sensitivity analyses were performed using bootstrapping to assess the robustness of reported results and presented in a cost-effectiveness plane (Figure 1).Results:The 393 patients’ mean age was 63 years (SD 9.6) and 74% were women. 109 patients were recruited during control periods (control group), and 284 patients were recruited during interventions periods (intervention group). Only the intervention group had a significant increase in EQ-5D-5L utility scores from baseline to 12 months follow-up (mean change 0.03; 95% CI 0.01, 0.05) with QALYs gained: 0.02 (95% CI -0.08, 0.12). The structured OA model cost approx. €301 p.p. with an additional €50 for the Healthy Eating Program. Total 12 months healthcare cost p.p. was €1281 in the intervention and €3147 in the control group, resulting in an incremental cost of -€1866 (95% CI -3147, -584) p.p. Costs related to surgical procedures had the largest impact on total healthcare costs in both groups. During the 12-months follow-up period, 5% (n=14) in the intervention compared to 12% (n=13) in the control group underwent joint surgery; resulting in a mean surgical procedure cost of €553 p.p. in the intervention as compared to €1624 p.p. in the control group. The ICER was -€93300, indicating that the OA care model resulted in QALYs gained and cost-savings. At a threshold of €27500, it is 99% likely that the OA care model is a cost-effective alternative.Conclusion:The results of the cost-utility analysis show that implementing a structured model for OA care in primary healthcare based on international guidelines is highly likely a cost-effective alternative compared to usual care for people with hip and knee OA. More studies are needed to confirm this finding, but this study results indicate that implementing structured OA care models in primary healthcare may be beneficial for the individual as well as for the society.Disclosure of Interests:None declared

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Optical spin-symmetry breaking for high-efficiency directional helicity-multiplexed metaholograms

Microsystems & Nanoengineering ◽

10.1038/s41378-020-00226-x ◽

2021 ◽

Vol 7 (1) ◽

Author(s):

Muhammad Ashar Naveed ◽

Muhammad Afnan Ansari ◽

Inki Kim ◽

Trevon Badloe ◽

Joohoon Kim ◽

...

Keyword(s):

High Efficiency ◽

Spin Symmetry ◽

Cost Effective ◽

Dielectric Materials ◽

Additional Degree ◽

Cost Effective Alternative ◽

Spin Orbit Interactions ◽

Smart Mobile ◽

The Cost ◽

Hydrogenated Amorphous

AbstractHelicity-multiplexed metasurfaces based on symmetric spin–orbit interactions (SOIs) have practical limits because they cannot provide central-symmetric holographic imaging. Asymmetric SOIs can effectively address such limitations, with several exciting applications in various fields ranging from asymmetric data inscription in communications to dual side displays in smart mobile devices. Low-loss dielectric materials provide an excellent platform for realizing such exotic phenomena efficiently. In this paper, we demonstrate an asymmetric SOI-dependent transmission-type metasurface in the visible domain using hydrogenated amorphous silicon (a-Si:H) nanoresonators. The proposed design approach is equipped with an additional degree of freedom in designing bi-directional helicity-multiplexed metasurfaces by breaking the conventional limit imposed by the symmetric SOI in half employment of metasurfaces for one circular handedness. Two on-axis, distinct wavefronts are produced with high transmission efficiencies, demonstrating the concept of asymmetric wavefront generation in two antiparallel directions. Additionally, the CMOS compatibility of a-Si:H makes it a cost-effective alternative to gallium nitride (GaN) and titanium dioxide (TiO2) for visible light. The cost-effective fabrication and simplicity of the proposed design technique provide an excellent candidate for high-efficiency, multifunctional, and chip-integrated demonstration of various phenomena.

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