Interchangeability Of Products Research Articles

Knowledge, Attitude, and Practice Towards Biosimilars and Interchangeable Products: A Prescriptive Insight by the Pharmacists.

BackgroundPharmacists being the drug experts need to be well aware of the applied handling of biosimilar medicines (BSMs). They are an integral educator, trailblazer, and advocate of biosimilar integration across all clinical settings. Therefore, the current study was conducted to assess the pharmacists’ knowledge, attitude, and practices of integrating BSMs into clinical practice.MethodsThe cross-sectional study was conducted from August 2019 to November 2019. The community pharmacies, clinical and academic settings in Karachi were approached for gathering the responses of pharmacists towards BSMs and interchangeable products using a 30-item survey form. Pearson correlation and independent sample t-test were used to identify the relationship among independent variables and the responses, considering p values <0.05 as statistically significant.ResultsOverall, there were 305 survey forms used with a response rate of 87.14%. More than 80% of the respondents have good knowledge about the definition, characteristics, safety and efficacy, compatibility, cost issues, and utilization of BSMs. Around half of the respondents (48.9%, [95% CI 46.6–51.2]) were confident in using BSMs in clinical practice. However, they were concerned about the BSM’s safety profile (45.2%, [95% CI 42.1–48.3]), quality (30.2%, [95% CI 28.3–32.1]), and efficacy issues (32.3%, [95% CI 31.2–37.5]).ConclusionThe findings revealed that pharmacists were well informed about the BSMs. However, some of the responses to the attitude demonstrated a lack of understanding of the application of that knowledge. The respondents persuaded that advanced patterns of diseases, product marketing stipulations, and need for better patient care drives higher demand for developing BSMs and were enthusiastic about gaining more insight to integrate BSMs into routine clinical practice.

ESTIMATION OF ECONOMIC ACTIVITY OF PARTNER ALLIANCES

The last decade has seen an increase in the interest of enterprises and organizations in new, more effective models of competition. Today choosing forms of partnership alliances for the survival and development of domestic enterprises is an urgent problem. They will bring enterprises to a new market and technological level due to the possibility of manufacturing complementary rather than interchangeable products, free choice of foreign partners taking into account their cultural and mental characteristics, organization of joint activities with partners access to information, opportunities to organize a fast and flexible process of preparation, coordination and decision-making, will bring them to a new market and technological level. The decision to join a certain form of alliance can significantly affect the actual mechanism of business competition, as the competition is not between individual companies, but between groups that are united by strategic interests. The economic efficiency of enterprises and organizations involved in cooperation depends not only on their own capabilities, but also on a number of factors of interaction between partner companies and the nature of partnerships.Solving problematic issues requires detailing the components of the effectiveness of partnership alliances, which are formed both within the enterprise and outside it in order to increase the level of innovation and the extention of integration processes. The purpose of the study is to analyze the activities of innovative enterprises involved in domestic and international partnerships. The analysis used scientific works of domestic scientists, statistics. The tendencies of change of the number of innovatively active enterprises, involved in partner alliances and alliance capacity by separate types of economic activity and types of partners has been investigated and determined. The results of the study showed that the largest number of partner alliances is formed in the field of testing, research and development. It has been proved that the partner alliances at the present stage of development of economic cooperation mostly include innovatively active non-industrial enterprises.Key words: cooperation, international cooperation, partnership alliance, innovatively active enterprise.

Policy of Multisource Drug Products in Latin America: Opportunities and Challenges on the Application of Bioequivalence In Vitro Assays.

The replacement of traditional in vivo bioequivalence studies by in vitro dissolution assays, based on the biopharmaceutical classification system (BCS), has emerged as an important tool for demonstrating the interchangeability of multisource products. This paper summarizes the current implementation of the BCS-based biowaiver for the development of multisource products in Latin America, and identifies several challenges and opportunities for greater convergence and application of BCS regulatory requirements. Differences and similarities between the current BCS-based biowaivers' guidelines proposed by two relevant regulatory agencies for the Latin American region (FDA and WHO) and the new ICH harmonization guideline were identified and compared. An update of the BCS-based biowaiver guideline for Latin American countries was also considered, based on the respective regulatory information on bioequivalence studies, which is publicly available. About 50% of the Latin American countries analyzed have no information on the implementation of any bioequivalence standards, while in the countries where bioequivalence studies are considered, the acceptance and application of BCS-based biowaiver requirements is quite heterogeneous. This situation contrasts with the international trend of global harmonization for BCS-based biowaiver guidance, suggesting the need in Latin America to identify opportunities and overcome challenges to improve the development of BCS-based biowaivers to avoid costly and time-consuming in vivo bioequivalence studies. The study shows that the region is in a position to improve access to safe and effective medicines at a reasonable cost by applying BCS-based biowaiver guidance.

The Computer Vision-based Tolerancing Callout Detection Model

Abstract Tolerancing symbols play an important role in mechanical product drawings, and they directly determine the functions, mating properties, interchangeability and working life of geometrical products. A symbolic tolerancing callout containing a set of symbols represents a set of pre-ordered operations with attributes. It includes an amount of knowledge from the drawing and standard documents, which is often reconstructed manually by engineers. Thus, at the same time, a symbolic tolerancing callout makes it difficult for the end-user to understand and interpret these callouts manually. To this end, this study puts forward a tolerancing callout detection model via the use of off-the-shelf costumer-grade cameras on current mobile devices for extracting and recognizing tolerancing callout blocks and symbols in them intelligently. This model has four core components: image preprocessing, callout location and extraction, symbol and character segmentation, and deep learning-based symbol recognition. The image preprocessing component is developed to remove the interferences on the target technical drawings through the corresponding morphological methods. This study proposes a novel solution on callout block locations and extractions in callout intensive scenarios since the callout locations and extractions can directly affect the accuracy of symbol and character recognitions. Then, Huff Transform and improved projection methods have been devised to symbol and character segmentations. Finally, this study constructed a convolutional neural network (CNN) to train a symbol recognition model. The experimental results show that the proposed model gains applicability on intelligent callout extractions and the corresponding symbol recognitions.

Cultural interchange in adventure education: exploring the interaction of participants and institutional cultures

ABSTRACT This study explores the interaction of participants and institutional cultures in adventure education (AE) through the qualitative method of educational criticism and connoisseurship. Three AE programmes were included in this study: a backpacking expedition (11 participants), a challenge course (29 participants), and a multi-activity adventure programme (21 participants). Through 183 hours of observation and 74 interviews, the thematic categories of cultural rigidity and cultural flexibility were identified. The AE institution exhibits cultural rigidity through guideline enforcement, jargon propagation, and value instillment, which results in participant adaptation. Conversely, the AE institution exhibits cultural flexibility through language accommodation, norm development, and goal setting, which results in participants’ ability to sustain selfhood. The implications of these findings include reaffirming the importance of attending to participant experiences in AE and the contention that striking a cultural balance in AE can promote productive cultural interchange as an aim of AE.

COMPETITIVENESS PROBLEMS OF UKRAINIAN ENTERPRISE AND TRADE IN THE GLOBALIZATION CONDITIONS

The problems of competitiveness of Ukrainian business and trade in the conditions of globalization are investigated. The contemporary challenges of globalization and its impact on the competitiveness of Ukrainian entrepreneurship are identified. Possibilities of introducing common rules for the regulation of competition at the international level are considered, in particular it is determined that certain unconventional measures-ideas, new joint legislative documents and special organizational structures are needed to regulate the constantly changing global game rules. Globalization is exacerbating problems of an ethnic nature. And it is no longer about competition of certain countries in the world markets of certain products, but about competition of multinational corporations, competition between sectors of the world economy that produce interchangeable products. As violators lose their national character, it is often impossible to apply the rules of a particular country. Here, common competition rules are necessary that would apply to a wide range of countries. Thus, as globalization rises up, the role of regulating competition at the international level increases significantly. Ukrainian enterprises need to carry out modernization, improve production, and develop product quality. The state must invest in the development of innovations, technology and knowledge. Economic policies to improve competitiveness should be pursued on an on-going basis. It is advisable to create an organizational infrastructure for entrepreneurship support in the form of techno parks, business incubators, networks of services to enterprises, in particular on the basis of public-private partnership; to facilitate the development of cluster networks. The task of the Ukrainian enterprise for today is to form and create new projects, to seek experience in the world and to improve a new product, to be able to sell its products in international markets. The article proposes measures for ensuring the competitiveness of Ukrainian enterprises through modernization of production, generation of breakthrough innovations and improvement of product quality, development of human potential; the development of the military-industrial complex (MIC) is important for Ukraine today. The importance of state support for the development of innovations, new technologies and investment of small and medium-sized enterprises is substantiated. Keywords : globalization, competitiveness, entrepreneurship development, trade, innovative entrepreneurship, enterprise modernization, clusters strategy.

Interchangeability of Essential Phospholipid Products

A significant share of the hepatoprotectors pharmaceutical market is represented by innovator and generic products containing essential phospholipids. One of the main issues in pharmacotherapy is confirmation of similarity between reference and generic products, which helps to assess their interchangeability. Therefore, it seems relevant to conduct comparative studies examining the products’ formulations (content of active pharmaceutical ingredients and excipients), dosage forms and routes of administration to identify characteristics that can affect interchangeability of essential phospholipid products. The objective of the study was to analyse interchangeability of generic and reference hepatoprotectors containing essential phospholipids. The nomenclature of essential phospholipids (oral (capsules), parenteral (solution for intravenous infusion and lyophilisate for solution for intravenous infusion), and topical (gel for cutaneous use) dosage forms) is given in accordance with the State Register of Medicinal Products, information storage and retrieval systems, and library databases (eLibrary, PubMed, CyberLeninka, ResearchGate).There was a significant difference in the content of phosphatidylcholine (29—93 %) in phospholipid substances produced by different manufacturers; minor differences were found in the quantitative composition of excipients in solutions, and significant differences were observed in the composition and quantities of excipients in capsules, which is most likely attributed to different production methods. The obtained data may be used to optimise pharmaceutical development and assess interchangeability of essential phospholipid products.

The content of patient counseling about interchangeable medicines and generic substitution in Finnish community pharmacies\xa0- a survey of dispensers

BackgroundGeneric substitution aims to increase the use of more affordable generic preparations and restrain the growth of medicine expenditures. Pharmaceutical staff plays an important role in generic substitution by implementing substitution and counseling customers. The aim of this study was to explore how Finnish dispensers inform pharmacy customers about interchangeable medicines and generic substitution and what customers ask dispensers about generic substitution and the reference price system.MethodsA questionnaire was sent to a random sample of dispensers (n = 1054) working in community pharmacies in spring 2018. The data was analyzed using frequencies, percentages and the Chi-square test and Fisher’s exact test. The open-ended questions were analyzed first using inductive content analysis and later with the quantitative methods mentioned above.ResultsThe final study material consisted of 498 questionnaires (response rate 51%). The main topics dispensers always informed customers about were the physician’s record in the prescription not to substitute the medicine (69%) and that the prescribed or purchased interchangeable medicine did not belong in the reference price band (59%). Topics mentioned often by dispensers dealt with customer’s chance to choose their medicine from among several alternative products (68%) and the manufacturer of the interchangeable medicines (66%). Differences in appearance (33%) or in composition (28%) of interchangeable products were the most common topics mentioned only when the customer asked about them. Of the respondents 17.6% always and 51.4% often informed the customer about the least expensive interchangeable product at the point of dispensing. Customers’ questions about the generic substitution and reference price system most commonly (82.4%) concerned the similarity of interchangeable medicines.ConclusionsFinnish dispensers provide customers with a wide range of information about different subjects when dispensing interchangeable medicines. Patient counseling generally meets the legislative requirements, except for price counseling. In future, information about generic substitution and interchangeable medicines should continuously be provided to customers both at pharmacies and elsewhere, e.g. through educational campaigns.

Comparative study of different meloxicam generic products with the brand product

This study aims to evaluate different products of meloxicam Table; Five meloxicam immediate-release generic products (15 mg Tables) were compared with the innovator, reference product, (Mobic®, Boehringer) to find the interchangeable product with the innovator product.&#x0D; Different physical tests were conducted including weight uniformity, thickness, diameter, hardness, friability and disintegration test. In addition, prediction of in-vivo behavior was assessed by measuring the dissolution profile of meloxicam for all the products. Similarity factor (f2) was calculated to compare between the dissolution profile of the generic products with the dissolution profile of innovator product.&#x0D; The results revealed that all the studied products are complied with the British Pharmacopoeia requirements. However, not all of them showed similar in-vitro profile to the brand product. Four out of five generic products, included in this study, showed similarity in dissolution profile to the brand one, which indicates possible bio-equivalency, with the advantages of money saving of using such generic products. One generic product showed similarity factor less than 50, which might give an indication that this generic product is not capable to be bioequivalent with the brand (innovator) product.&#x0D; Overall, this study can be considered an important applicable study that gives an indication about the in-vivo performance of different products. In addition, the study demonstrates the applicability of a simple in-vitro dissolution study as a surrogate way of assessing product bioavailability instead of an expensive and complicated in-vivo bioequivalent study.&#x0D;

Comparative study of different meloxicam generic products with the brand product

This study aims to evaluate different products of meloxicam Table; Five meloxicam immediate-release generic products (15 mg Tables) were compared with the innovator, reference product, (Mobic®, Boehringer) to find the interchangeable product with the innovator product. Different physical tests were conducted including weight uniformity, thickness, diameter, hardness, friability and disintegration test. In addition, prediction of in-vivo behavior was assessed by measuring the dissolution profile of meloxicam for all the products. Similarity factor (f2) was calculated to compare between the dissolution profile of the generic products with the dissolution profile of innovator product. The results revealed that all the studied products are complied with the British Pharmacopoeia requirements. However, not all of them showed similar in-vitro profile to the brand product. Four out of five generic products, included in this study, showed similarity in dissolution profile to the brand one, which indicates possible bio-equivalency, with the advantages of money saving of using such generic products. One generic product showed similarity factor less than 50, which might give an indication that this generic product is not capable to be bioequivalent with the brand (innovator) product. Overall, this study can be considered an important applicable study that gives an indication about the in-vivo performance of different products. In addition, the study demonstrates the applicability of a simple in-vitro dissolution study as a surrogate way of assessing product bioavailability instead of an expensive and complicated in-vivo bioequivalent study.

GLOBALIZATION AS A FORM OF CULTURAL INTERACTION IN CONTEMPORARY DESIGN DEVELOPMENT

The article is devoted to the problem of traditional cultures functioning during the period of universal globalization and unification in the era of the information revolution. The purpose of the article is to identify the possibilities of design as an instrument for the preservation and development of culture. The task is to identify the factors that ensure the interconnection of the philosophical, scientific, technical, aesthetic and environmental spheres of global culture on the one hand, and productive interchange of achievements of regional and national cultures on the other hand. It is revealed that today, along with the globalization tendencies and unification in many spheres of human activity, for each people its genetic code, embedded in its own material culture, is best able to perform such important functions as harmonization of the environment, streamlining and orientation in information.Key words: traditional culture, design, globalization, identity, local design.

MULTICULTURALISM AND ASPECTS OF GLOBALISATION IN KIRAN DESAI’S INHERITANCE OF LOSS

Indian English Literature pertains to the body of work by writers from India, who pen strictly in the English language and whose native or co-native language could be one of the numerous regional and indigenous language of India. English literature in India is also intimately linked with the works of associates of the Indian Diaspora. Among other writers, Kiran Desai is one of the most renowned writers in the Indian English Literature. With Kiran Desai, a literary tradition is reborn. One of the major themes in the novel is multiculturalism. Multiculturalism relates to communities containing multiple cultures. The term is used in two broad ways, either descriptively or normatively. As a descriptive term it usually refers to the simple fact of cultural diversity. It is generally applied to the demographic make-up of a specific place, sometimes at the organizational level, eg: school, businesses, cities, or nations. As a normative term, it refers to ideologies or policies that promote this diversity or its institutionalization. In this sense, multiculturalism is a society at ease with the rich tapestry of human life and the desire amongst people to express their own identity in the manner they see as fit. Such ideologies or policies vary widely, including country to country. Another major theme in the novel is globalization, which is a process of international integration arising from the interchange of world views, products, and other aspects of culture. Advances in transportation and telecommunications infrastructure, including the rise of the telegraph and its posterity the Internet, are majorfactors in globalization, generating further interdependence of economic and cultural activities. The term globalization has been increasing use since the mid-1980s and especially since the mid-1990s. The term globalization is derived from the word globalize, which refers to the emergence of an international network ofsocial and economic systems. This paper attempts to analyze Kiran Desai’s novel The Inheritance of Loss to bring out the various aspects of multicultural clashes and globalization.

FDA guidance on interchangeable biological products

FDA guidance on interchangeable biological products

Authorisation of Non-Innovator Biotherapeutic (Biosimilar) Products in the USA

European competent authorities began to elaborate scientific principles of development of non-innovator biotherapeutic (biosimilar) products in the early noughties, and in 2009 these principles were approved at the WHO International Conference in Seoul gathering participants from countries with a well-developed pharmaceutical industry. The USA adopted the law on biosimilar products in 2012, it was based on the documents and recommendations prepared by the EMA and approved by the WHO. In 2015, the FDA published the new revised versions of the guidelines dealing with biosimilar products. The US regulatory requirements for development and authorisation of biosimilar products are based on a step-by-step comparative assessment of biosimilar and innovator products in terms of their quality, efficacy, and safety in accordance with the WHO/EMA recommendations. At the same time the US regulatory requirements differ from those of other national authorities, including EMA (WHO), when it comes to the design of comparative quality studies (studies of products’ physicochemical and biological properties), the assignment of International Non-Proprietary Names and the interchangeability of biosimilar products.

The Age of Machinery: Engineering the Industrial Revolution, 1770–1850 by Gillian Cookson

Reviewed by: The Age of Machinery: Engineering the Industrial Revolution, 1770–1850 by Gillian Cookson Barbara Hahn (bio) The Age of Machinery: Engineering the Industrial Revolution, 1770–1850. By Gillian Cookson. Suffolk: Boydell Press, 2018. Pp. 324. Paperback $25.95. This engaging, erudite study investigates the firms and people who made the machines of the Industrial Revolution, which Cookson defines classically, as the mechanization of British textiles 1770-1850. Trained in economic history, Dr. Cookson (who once collaborated with this reviewer) changes a conversation that focused on wages and coal prices, or on Enlightenment ideas, toward the motivations, education, and experiences of the early textile engineers. Along the way she dispenses with myths, including the anachronistic idea of "individualistic entrepreneurs," and any contribution of clockworks to textile machinery after 1800. Her machine-makers, "acting as any artisan would when faced with a changing world," nonetheless created a "new culture, beyond artisanship" in their works (pp. 125–26). How, she begins, "had it been possible to build a new high-tech industry practically from scratch?" (p. 2) The answer, of course, is that people made it from what already existed. Cookson acknowledges that the textile engineering sector was powerfully transformative but shows how slowly it consolidated out of older artisanal trades. By 1790, specialists in making textile machinery had entered the historical record (first by testifying against the originality of Richard Arkwright's patents), but the trade became recognizable only after 1800. Before then, woodworking was a crucial component of textile engineering. About 1805, casting iron frames and working iron sheet metal became central to making new devices, but these were still manual skills. In the early 1820s, "a climactic wave of innovation in textiles" began "fully exploiting steam-powered machine tools and interchangeable production" of the machines intended for use in textile factories (pp. 104–5). Nonetheless, the sector remained transitional until the 1840s, with some firms still filing parts to fit together, using calipers with tolerances no finer than 1/32 of an inch. After that point, however, "machines made machines" and more firms had begun factory production of textile machinery (p. 232). This periodization identifies technological closure [End Page 630] among customers too, whose development of standardized cloth-making processes accompanied the history of building the machinery they used. The language of the industry reflected its origins, as textile engineers "habitually labelled themselves, in . . . official documents, by their earliest trade" (p. 77). Apprenticeship also flourished in textile engineering into the nineteenth century, even as it faded in more traditional trades and in the textile mills themselves (where pauper children had regularly been apprenticed into the first mills, in compliance with Elizabethan Poor Laws). Tinsmithing and ironworking skills also had a long history in the forges and furnaces of the region, combined under the control of a few families in the eighteenth century. The new engineering flourished in communities bound by kinship and religion, and created a sector in which journeymen could tramp in time-honored fashion among firms to learn and spread new skills. As the new engineering solidified, the best firms replicated the community structures in which they had developed. What of innovation? Cookson's comprehensive, invaluable appendices provide family trees of engineers, their training stints and firms. These networks undermine invention myths that know only the patented devices of James Hargreaves, Richard Arkwright, Samuel Crompton, and Edmund Cartwright. Her men did less inventing than "making things work," which often involved getting fibers prepared in more regular ways to enter the more celebrated, if regularly modified, machinery. Within firms, "The knack was to manage the imperfect while chasing perfection" (pp. 229, 231). Her exploration of subcontracting is an important aid to understanding what happened during industrialization, and it helps account for the importance of family and community in shaping the sector. Maintenance also receives its due, as Cookson remarks how many mechanics worked in textile factories rather than foundries. So does the throstle, a spinning device named for singing like a bird, too often neglected in progress-oriented accounts. Cookson's intimate familiarity with places like Keighley and Chowbent and men like Benjamin Gott and Matthew Murray may disorient some readers less familiar with the region, the...

OP130 Evidence-Informed Policy For Biologic Medicines In Brazil

IntroductionThe Department of Sciences and Technology (Decit) of the Brazilian Government has played a vital role in drafting of the National Policy for Biologic Medicines. Decit has provided methodological support to the working group, conducting a rapid review and a rapid evidence synthesis to subsidize decisions and recommendations.MethodsWe used the Methodological Guidelines for the Elaboration of Evidence Synthesis for Health Policies, which is a product of our own team, based on the SUPporting POlicy relevant Reviews and Trials (SUPPORT) Tools for evidence-informed health Policymaking.ResultsThe Decit team participated in the key steps to develop an evidence-informed policy. Our product, “Barriers to Access to Biologic Products: a Rapid Review” was used for the prioritization of health problems and the description of the problem. We then proceeded to the evidence synthesis planning and definition of the research question from an acronym. Together with the coordination of the working group, we decided to tackle the problem of interchangeability of biologic products motivated solely by economic factors in a synthesis of policy evidence. Our evidence synthesis went so far as to describe policy options. The working group used this product to inform a Policy Dialog.ConclusionsThis was the first time that the Decit team provided hands-on methodological assistance the development of a health policy. Not all steps recommended in the SUPPORT Tools were feasible due to time restraints. We observed that rapid evidence synthesis products were helpful to inform decision-making.

Cultural, economic, and ecological factors influencing management of wild plants and mushrooms interchanged in Pur\xe9pecha markets of Mexico

BackgroundTraditional markets outstandingly contribute to conservation of biocultural diversity, social relations, and cultural values. These markets reflect life strategies and forms people of a region interact with their biodiversity and territories, as well as traditional ecological knowledge and management practices. To understand the factors motivating plant and mushroom management, we analyzed the resources cultural and economic values, their role in people’s subsistence, and the relation of these values with the resources spatial and temporal availability. Our study based on the supposition that traditional markets are settings of interchange of resources with the highest importance for people’s life in a region. Also, that the cultural, economic, and ecological factors influence values of the resources, and the demand on them determine pressures on the most valuable resources which, when scarce, motivate management innovation, otherwise become extinct.MethodsWe documented cultural, economic, and ecological aspects, as well as management techniques of wild and weedy plants and mushrooms interchanged in three traditional markets of the Pátzcuaro Lake region, in central-western Mexico. For doing that, from February 2015 to March 2018, we conducted 175 visits to markets and 89 semi-structured interviews to producers, gatherers, and sellers of wild and weedy plants and mushrooms. Based on participant observation and interviews, we identified variables related to culture, economic, and ecological aspects, as well as management regimes of resources and management systems, which were documented and used as indicators for quantitative analyses. Through principal components analyses (PCA), we determined the indexes of cultural and economic importance (ICEI), management intensity (IMI), and ecological risk (IR) of the resources studied. For conducting that, we classified plant and mushroom species according to their cultural, economic, ecological, and technological indicators, respectively. The score of the first principal component was considered as the index for each group of variables, respectively. To identify relations between cultural importance and risk, we performed linear regression analyses between ICEI and IR indexes.ResultsWe recorded 57 species of wild and weedy plants used as food, medicine, and ornamental, and 17 species of edible mushrooms. The variables with the highest weight in the ICEI are related to the need of a resource according to people, its recognizing, the number of communities and markets offering it in markets, its explicit preference expressed by people, the effort invested in obtaining it, and the form it is interchanged. Gathering is practiced in all mushrooms and wild and weedy plants from forests and agricultural areas; 11 species in addition receive 1 or more forms of management (enhancing, selective let standing, propagation through seeds or vegetative parts, transplantation, and/or protection). The management intensity and complexity are explained by variables related to management practices and systems. Plants receiving selective management have the higher management intensity. Silvicultural management (in situ management in forests) was recorded in all species of mushrooms, as well as in more than 80% of medicinal, ceremonial and ornamental plants, and in more than 50% of the edible plants. In agricultural systems, people manage more than 90% of the edible plants recorded to be under a management regime, 25% of the managed medicinal plants, and 30.7% of the managed ceremonial and ornamental plants. In homegardens, people manage 41.6% of the medicinal plants recorded and 26.6% of the edible plants, to have them available near home. Nearly 63% of the species interchanged in the markets studied are gathered in forests without any other management form. In this group are included all mushroom species, 61.5% of ceremonial/ornamental plants, 50% of medicinal, and 33.3% of edible plants. The linear regression between ICEI an IER is significantly negative for edible species with high management intensity R2 = 0.505 (p = 0.0316), because of their management. But in medicinal and ornamental plants, the risk is high if the cultural importance increases, even when management practices like transplanting and propagation in homegardens are carried out.ConclusionsTraditional markets are settings of interchange of products, knowledge, and experiences, where the ongoing factors and processes motivating management innovation can be identified and documented. This approach allows documenting processes occurring at regional level but would be benefited from deeper studies at local level in communities.

Regulation of biosimilar medicines and current perspectives on interchangeability and policy.

Competition arising from the increasing availability of biosimilar medicines has resulted in healthcare savings and has provided greater patient access to high cost therapeutics in Europe. The biosimilar market in the USA is relatively new so the full impact of biosimilar availability remains to be seen. Educational initiatives relating to the use of biosimilar medicines are currently being undertaken by regulators, policy makers and industry. The debate on biosimilars has moved on from the appropriateness of the regulatory framework which governs their approval, to the practice of interchangeability. Interchangeability is an important issue for healthcare professionals but different definitions and regulatory frameworks exist in the USA and Europe. In the USA, an interchangeable biological product is a biosimilar which may be substituted by a pharmacist, subject to local State policies. The interchangeability of a biosimilar with its reference medicine will be evaluated by the United States Food and Drug Administration (FDA) in cases where approval as an 'interchangeable product' is sought. In contrast, the European Medicines Agency (EMA) does not assess or make recommendations on interchangeability, therefore, in Europe, interchangeability does not mean substitution but is generally physician-led or driven by national policy. This paper provides an overview of the regulation of biosimilar medicines. Challenges associated with the demonstration of interchangeability and practical considerations relating to switching are also discussed. Finally, we present policies that have been adopted to date in several European countries, the USA and Australia, which aim to promote the use of biosimilar medicines.

Field measurements and statistical analysis of perforated grating surfaces for grating fresh cassava into mash in Ghana

Processing of cassava into mash requires grating of fresh cassava tubers through the abrasive action of the grating surfaces of cassava graters that grind against the cassava and transforms it into mash. Over the years, improved cassava graters have been designed and made available on the market. In spite of improvements in design, there are no standards for the manufacture of grating surfaces and this affects interchangeability of the product. Mechanised grating of fresh cassava into mash contributes to reduce postharvest losses of cassava, increase its shelf life and improve food security. However, majority of the cassava grating surfaces are poorly made with substandard measurements that affect the desired particle size of mash for gari, a staple food for millions of people in West Africa. This study assessed cassava grating surfaces focusing on the abrasive elements (tooth diameter and inter-tooth spacing). Qualitative data were gathered from local metal fabricators and female gari processors in separate focus group discussions. The purpose was to gather the narratives underlying the issues being studied so as to complement and enrich the quantitative data. 112 tooth diameters and 112 inter-tooth spacing of perforated cassava grating surfaces were randomly measured in 16 different study areas in 3 regions of Ghana, namely Western, Central and Ashanti. Results from the qualitative data showed that grating of cassava was done repeatedly (about 2-3 times) before reaching the desired particle size of mash for gari. Most customers desire grating surfaces that ensure effective contact between the cassava and the metal grating surface to reduce grating time. Results from the field measurements showed high variation in existing tooth diameters (min=1.80, max=4.50 mm) and inter-tooth spacings (min=3.50, max=12.00 mm) that resulted in non-uniform particle size of cassava mash. Using statistical analysis, tooth diameters (min=3.18, max=3.42mm) and inter-tooth spacings (min=7.12, max=7.78mm) were determined at 95% confidence interval. For practical purposes, tooth diameter of 3 mm and inter-tooth spacing of 8 mm are recommended. The availability of such data will contribute significantly to standardise perforated cassava grating surfaces to achieve product interchangeability and desired quality of grated mash for gari. This will contribute to improve the manufacture of cassava graters and sustainable gari processing business in Ghana and Africa. Keywords: Fresh cassava, cassava grating surface, gari, food quality, Ghana

Generic Substitution of Orphan Drugs for the Treatment of Rare Diseases: Exploring the Potential Challenges.

Generic drugs are important components of measures introduced by healthcare regulatory authorities to reduce treatment costs. In most patients and conditions the switch from a branded drug to its generic counterpart is performed with no major complications. However, evidence from complex diseases suggests that generic substitution requires careful evaluation in some settings and that current bioequivalence criteria may not always be adequate for establishing the interchangeability of branded and generic products. Rare diseases, also called orphan diseases, are a group of heterogeneous diseases that share important characteristics: in addition to their scarcity, most are severe, chronic, highly debilitating, and often present in early childhood. Finding a treatment for a rare disease is challenging. Thanks to incentives that encourage research and development programs in rare diseases, several orphan drugs are currently available. The elevated cost of orphan drugs is a highly debated issue and a cause of limited access to treatment for many patients. As patent protection and the exclusivity period of several orphan drugs will expire soon, generic versions of orphan drugs should reach the market shortly, with great expectations about their impact on the economic burden of rare diseases. However, consistent with other complex diseases, generic substitution may require thoughtful considerations and may be even contraindicated in some rare conditions. This article provides an overview of rare disease characteristics, reviews reports of problematic generic substitution, and discusses why generic substitution of orphan drugs may be challenging and should be undertaken carefully in rare disease patients.