Current Regulatory Standpoint on Evaluating the Bioequivalence of Different Classes of Generic Drugs - Is the Evaluation in the Right Direction?

2019 ◽  
Vol 20 (10) ◽  
pp. 835-844 ◽  
Author(s):  
Francis Micheal ◽  
Mohanlal Sayana ◽  
Balamurali Musuvathi Motial
Keyword(s):  
Generic Drugs ◽  
Bibliographic Databases ◽  
Eligibility Criteria ◽  
Individual Bioequivalence ◽  
Population Bioequivalence ◽  
Standard Tool ◽  
Review Question ◽  
Guidance Documents ◽  
The Right

Background: The concept of evaluating bioequivalence has changed over a period of time. Currently, the Average Bioequivalence approach (ABE) is the gold standard tool for the evaluation of generics. Of late, many debates had arisen about employing ABE approach for the appraisal of all drug categories. This review aims to examine the limitations of ABE approach and the significances of Population Bioequivalence (PBE) and Individual Bioequivalence (IBE) approach, current regulatory thinking for assessing different categories of the drug, whether they are adequately assessed, and the evaluation is in the right direction. Methods: We carried out an organized search of bibliographic databases for peer-reviewed research literatures, regulatory recommendations, guidance documents using a focused review question and eligibility criteria. The standard tools were used to appraise the quality of retrieved documents and to make sure the authenticity of the data. Results: In total 73 references were used in the review, the majority of the references (guidance documents) were from the different regulatory agencies and product-specific guidance. There were 29 product-specific guidance from USFDA and EMA. The limitations of the ABE approach were discussed in detail along with the significances of Population Bioequivalence (PBE) approach and Individual Bioequivalence (IBE) approaches. Conclusion: It is apparent from the review that IBE approach is a precise method for evaluating the drugs as it answers drug interchangeability (prescribability and switchability). IBE approach is followed by PBE approach and ABE approach for the evaluation of different categories of drugs in terms of precision.

Caring experiences of family caregivers of patients with heart failure: A meta-ethnographic review of the past 10 years

2020 ◽  
Vol 19 (6) ◽  
pp. 473-485 ◽  
Author(s):  
Eun Young Kim ◽  
Seieun Oh ◽  
Youn-Jung Son
Keyword(s):  
Heart Failure ◽  
Family Caregivers ◽  
Healthcare Providers ◽  
Qualitative Studies ◽  
Bibliographic Databases ◽  
Eligibility Criteria ◽  
Essential Information ◽  
Patients With Heart Failure ◽  
Caregiving Roles

Background: Living with heart failure, a debilitating disease with an unpredictable course, requires ongoing adaptation and management not only from patients but also from their families. Family caregivers have been known to be key facilitators of self-management of heart failure. An integrative understanding of the experiences of family caregivers will provide essential information for improving the quality of life of persons with heart failure and their families. Aims: This study aimed to integrate and synthesize the findings of qualitative studies on family members’ experiences of caring for patients with heart failure. Methods: We employed the meta-ethnography methodology. Five electronic bibliographic databases were used to retrieve studies published from April 2009–March 2019 that explored family caregivers’ experiences of caring for patients with heart failure. Twelve qualitative studies were finally included for the synthesis, based on the eligibility criteria. Results: Three themes were identified: “shouldering the entire burden,” “starting a new life,” and “balancing caregiving and everyday life.” These three themes illustrate how family caregivers fulfilled caregiving roles, what helped them juggle their multiple responsibilities, and how they struck a balance between life as caregivers and individuals in their own right. Conclusion: This review provides a deeper understanding of family caregivers’ experiences of caring for patients with heart failure. The findings can help healthcare providers in the development and implementation of tailored interventions for both patients and family caregivers.

scholarly journals Recommendations for SARS-CoV-2/COVID-19 testing: a scoping review of current guidance

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e043004
Author(s):  
Ingrid Arevalo-Rodriguez ◽  
Pamela Seron ◽  
Diana Buitrago-García ◽  
Agustin Ciapponi ◽  
Alfonso Muriel ◽  
...  
Keyword(s):  
Scoping Review ◽  
Methodological Quality ◽  
Chest Ct ◽  
Respiratory Pathogens ◽  
X Rays ◽  
Rt Pcr ◽  
Eligibility Criteria ◽  
Guidance Documents ◽  
Evidence Database

BackgroundTesting used in screening, diagnosis and follow-up of COVID-19 has been a subject of debate. Several organisations have developed formal advice about testing for COVID-19 to assist in the control of the disease. We collated, delineated and appraised current worldwide recommendations about the role and applications of tests to control SARS-CoV-2/COVID-19.MethodsWe searched for documents providing recommendations for COVID-19 testing in PubMed, EMBASE, LILACS, the Coronavirus Open Access Project living evidence database and relevant websites such as TRIP database, ECRI Guidelines Trust, the GIN database, from inception to 21 September 2020. Two reviewers applied the eligibility criteria to potentially relevant citations without language or geographical restrictions. We extracted data in duplicate, including assessment of methodological quality using the Appraisal of Guidelines for Research and Evaluation-II tool.ResultsWe included 47 relevant documents and 327 recommendations about testing. Regarding the quality of the documents, we found that the domains with the lowest scores were ‘Editorial independence’ (Median=4%) and ‘Applicability’ (Median=6%). Only six documents obtained at least 50% score for the ‘Rigour of development’ domain. An important number of recommendations focused on the diagnosis of suspected cases (48%) and deisolation measures (11%). The most frequently recommended test was the reverse transcription-PCR (RT-PCR) assay (87 recommendations) and the chest CT (38 recommendations). There were 22 areas of agreement among guidance developers, including the use of RT-PCR for SARS-Cov-2 confirmation, the limited role of bronchoscopy, the use chest CT and chest X-rays for grading severity and the co-assessment for other respiratory pathogens.ConclusionThis first scoping review of recommendations for COVID-19 testing showed many limitations in the methodological quality of included guidance documents that could affect the confidence of clinicians in their implementation. Future guidance documents should incorporate a minimum set of key methodological characteristics to enhance their applicability for decision making.

scholarly journals Risk factors for postanesthetic emergence delirium in adults: A systematic review and meta-analysis

2022 ◽  
Author(s):  
Miao He ◽  
◽  
Zhaoqiong Zhu ◽  
Min Jiang ◽  
Xingxing Liu ◽  
...  
Keyword(s):  
Risk Factors ◽  
Multivariate Regression ◽  
Observational Studies ◽  
Meta Analysis ◽  
Inclusion Criteria ◽  
Eligibility Criteria ◽  
Nerve Blocks ◽  
Emergence Delirium ◽  
Review Question

Review question / Objective: Patientor population: patients with emergence delirium; Exposure: anaesthesia and surgery; Control: patients with no emergence delirium; Outcome: risk factors; Study design: meta-analysis. Eligibility criteria: To ensure the quality of this meta-analysis, inclusion criteria was decided before we carried out the search. These criteria were: (a) Original researches that carried out in observational studies. (b)Adult patients who were extubated and recovered at PACU, operation room, or intensive care unit (ICU) after surgeries and anesthesia (including general and neuraxial anesthesia, peripheral nerve blocks and sedation). (c) Risk factors for delirium must be assessed with odds ratio (OR) with 95% confidence interval (CI). Researches must present the results of multivariate regression to be considered eligible for inclusion, since multivariate analysis results shall be used to identify variables eligible for meta-analysis. (d) Full-text available literatures.

ANALYSIS OF REGULATIONS REGARDING THE SETTLEMENT OF ISSUES ON THE REMOVAL AND RECOVERY OF PLANTATIONS IN THE RIGHT-OF-WAY OF PUBLIC ROADS

2020 ◽  
pp. 55-60
Author(s):  
Nataliia Kharytonova ◽  
Olha Mykolaienko ◽  
Tetyana Lozova
Keyword(s):  
Traffic Safety ◽  
Climatic Factors ◽  
Visual Orientation ◽  
Right Of Way ◽  
Adverse Weather ◽  
Overhead Power Lines ◽  
The Right ◽  
Neck Diameter ◽  
Proper Operation

Greening of roads contributes to the protection of roads and their elements from influence of adverse weather and climatic factors; it includes the measures for improvement and landscaping of roads, ensures the protection of roadside areas from transport pollution, provides visual orientation of drivers. The solution of these issues will ensure creation and maintenance of safe and comfortable conditions for travelers. Green plantings in the right-of-way road area include woody, bushy, flower and grass vegetation of natural and artificial origin. For proper operation of public roads and satisfaction of other needs of the industry, there may be the need in removing the greenery. The reason for the removal of greenery in the right-of-way road area may be due to the following factors: construction of the architectural object, widening of the motor road, repair works in the security zone of overhead power lines, water supply, drainage, heating, telecommunications facilities, cutting of hazardous, dry and fautal trees, as well as self-grown and brushwood trees with a root neck diameter not exceeding 5 cm, elimination of the consequences of natural disasters and emergencies. The removal of plantations in the right-of-way area is executed in order to ensure traffic safety conditions and to improve the quality of plantations composition and their protective properties. Nowadays, in Ukraine there is no clear procedure for issuing permits for removing of such plantations. In order to resolve this issue, there is a need in determining the list of regulations in the area of forest resources of Ukraine and, if needed, the list of regulatory acts that have to be improved; to prepare a draft of the regulatory legal act that would establish the procedure of plantations cutting, the methodology of their condition determination, recovery costs determination, the features of cutting. Keywords: plantations, cutting, right-of-way, woodcutting permit, order.

Modifikasi Model Pembelajaran Problem Based Learning (PBL) dengan Strategi Pembelajaran Tugas dan Paksa

2019 ◽  
Vol 2 ◽  
Author(s):  
Tita Mila Mustofani ◽  
Ita Hartinah
Keyword(s):  
Critical Thinking ◽  
Learning Strategies ◽  
Student Motivation ◽  
Problem Based Learning ◽  
Learning Model ◽  
Learning Material ◽  
Task Strategies ◽  
The Right ◽  
Increasing Student Learning

This writing aims to help teachers to increase motivation, activity, creativity, and critical thinking of students in solving problems in class. The way to increase student motivation in learning in class is to choose the right learning model with ongoing learning material. One learning model that increases students' creativity and critical thinking in problem solving is a Problem Based Learning (PBL) learning model. To improve students' insights in order to easily solve problems there is a need to do tasks, if students do not do the task then they must accept the agreed upon consequences when making learning contracts, thus modifying the Problem Based Learning (PBL) learning model with task strategies and forced. The results of the modification of learning with the Problem Based Learning (PBL) learning model through forced and forced strategies are expected to improve the learning process so that students become more disciplined and do not waste time doing assignments. The advantages of modifying the Problem Based Learning (PBL) learning model with task and forced learning strategies are increasing student learning motivation, improving the quality of learning, training students' understanding by giving assignments continuously, teaching discipline to students in order to be accountable for tasks assigned, and reducing laziness in students.

THE VALUE OF LOVE IN THE SYSTEM OF FORMATION OF THE PROFESSIONAL MATURITY OF THE EDUCATOR

2020 ◽  
Vol 1 (10(79)) ◽  
pp. 12-18
Author(s):  
G. Bubyreva
Keyword(s):  
Russian Federation ◽  
The State ◽  
Educational Process ◽  
Wide Range ◽  
The Family ◽  
The Russian Federation ◽  
The Government ◽  
The Individual ◽  
The Right

The existing legislation determines the education as "an integral and focused process of teaching and upbringing, which represents a socially important value and shall be implemented so as to meet the interests of the individual, the family, the society and the state". However, even in this part, the meaning of the notion ‘socially significant benefit is not specified and allows for a wide range of interpretation [2]. Yet the more inconcrete is the answer to the question – "who and how should determine the interests of the individual, the family and even the state?" The national doctrine of education in the Russian Federation, which determined the goals of teaching and upbringing, the ways to attain them by means of the state policy regulating the field of education, the target achievements of the development of the educational system for the period up to 2025, approved by the Decree of the Government of the Russian Federation of October 4, 2000 #751, was abrogated by the Decree of the Government of the Russian Federation of March 29, 2014 #245 [7]. The new doctrine has not been developed so far. The RAE Academician A.B. Khutorsky believes that the absence of the national doctrine of education presents a threat to national security and a violation of the right of citizens to quality education. Accordingly, the teacher has to solve the problem of achieving the harmony of interests of the individual, the family, the society and the government on their own, which, however, judging by the officially published results, is the task that exceeds the abilities of the participants of the educational process.  The particular concern about the results of the patriotic upbringing served as a basis for the legislative initiative of the RF President V. V. Putin, who introduced the project of an amendment to the Law of RF "About Education of the Russian Federation" to the State Duma in 2020, regarding the quality of patriotic upbringing [3]. Patriotism, considered by the President of RF V. V. Putin as the only possible idea to unite the nation is "THE FEELING OF LOVE OF THE MOTHERLAND" and the readiness for every sacrifice and heroic deed for the sake of the interests of your Motherland. However, the practicing educators experience shortfalls in efficient methodologies of patriotic upbringing, which should let them bring up citizens, loving their Motherland more than themselves. The article is dedicated to solution to this problem based on the Value-sense paradigm of upbringing educational dynasty of the Kurbatovs [15].

Evaluation of staff in Healthcare Companies

2020 ◽  
Author(s):  
Troncone Raffaella ◽  
Coda Marco
Keyword(s):  
Social Context ◽  
Evaluation System ◽  
Daily Life ◽  
Good Health ◽  
Rehabilitation Services ◽  
Individual Contribution ◽  
Personnel Evaluation ◽  
Good Evaluation ◽  
The Right

Evaluation is at the basis of any social context where all individuals are simultaneously "evaluated" and "evaluators" in all areas of daily life. The goal of a good evaluation system is to encourage staff to do "Good Health" through the provision of quality prevention, diagnosis, treatment and rehabilitation services. The main reasons that lead to the evaluation of the personnel lie in the inevitable and primary importance of the human resource in achieving the corporate objectives, and by the pressing need for the quality of the service provided to the citizen, as well as the legitimate need of the employee to differentiate, clarifying its specificities and its own individual contribution to the general objectives of the company. In the working context, the "personnel evaluation" assumes a fundamental importance, if managed with the right criteria, in order to make the employee not a simple pawn to move and manage for use and consumption of the organization, but an integral part of the organization itself.

Has the Time Come to Employ Population and Individual Bioequivalence for the Evaluation of Generics?

2020 ◽  
Vol 21 (2) ◽  
pp. 112-125
Author(s):  
Francis Micheal ◽  
Mohanlal Sayana ◽  
Rajendra Prasad ◽  
Balamurali Musuvathi Motilal
Keyword(s):  
Therapeutic Index ◽  
Bioequivalence Study ◽  
Open Label ◽  
Statistical Parameters ◽  
Population Mean ◽  
Average Bioequivalence ◽  
Individual Bioequivalence ◽  
Population Bioequivalence ◽  
Enteric Coated ◽  
Bioequivalence Assessment

Background: Bioequivalence studies are a vital part of drug development. The average bioequivalence approach is the standard method of assessment to conclude whether the generic product is bioequivalent to the innovator product. Of late, debates are on whether the average bioequivalence approach adequately addresses drug interchangeability as it considers only population mean for the evaluation especially when highly variable drug products and narrow therapeutic index drugs are dealt with. Hence, the alternative approaches like population bioequivalence and individual bioequivalence assessment approaches emerge as they consider inter/intra-subject variance and subject- by-formulation variance along with population mean. Objectives: The objective of the study was to apply different bioequivalence assessment approaches in a replicate bioequivalence study to evaluate the drug interchangeability. Methods: This was an open-label, single-dose, randomized, balanced, two-treatment, three-period, three-sequence, partial replicate crossover bioequivalence study of omeprazole enteric-coated tablet 20 mg conducted on 48 normal healthy subjects under fed conditions. The plasma concentration of omeprazole was analyzed by a validated bioanalytical method to determine the pharmacokinetic and statistical parameters to assess average bioequivalence, population bioequivalence, and individual bioequivalence. Results: In this study, test formulation was shown to be bio-inequivalent to the reference formulation by average bioequivalence, population bioequivalence, and individual bioequivalence approaches. Conclusion: The outcome of the evaluation clearly states that the bioequivalence outcome of all these approaches are the same. Obviously, it does not mean that these three approaches provide the same outcome though the consideration of variances varies. Certainly, population bioequivalence and individual bioequivalence approach will be more accurate for the assessment of drug interchangeability.

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

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