The health care industry’s involvement with biosimilar policies suggests that building coalitions and reducing opposition are critical factors for interest group success. As government decision-makers wrestle with how to handle a perplexing category of prescription drugs, companies and patient groups alike receive ample opportunities to contribute to the policymaking process. When stakeholders in the biosimilar arena – including manufacturers, physicians, and patients – unite, we see that the United States government takes steps toward fixing the policy problem. This occurred most recently with policies about biosimilar drug coverage under Medicare Part D and reimbursement under Medicare Part B. In both cases, stakeholders took a united stance and consequently faced no opposition. On the contrary, internal industry disputes between brand and biosimilar manufacturers about patent exclusivity laws and interchangeability rules revealed the nuances of biosimilar policy and the challenge that regulators face when they receive mixed messages. Across all of their efforts, biosimilar stakeholders pursued numerous strategies which may have contributed to their successes. They focused on niche issues and used their lobbying expertise to actively submit comments, testify in hearings, and meet with government officials; however, the differentiating tactic between the industry’s successes and failures was whether they formed coalitions. By coming together, stakeholders lowered their chances of facing opposition. A closer analysis of the politics of biosimilars illustrates that when they present a united front to lawmakers, interest groups reduce the likelihood of opposition and successfully influence policy change.

While postcraniometric sex estimation has shown promising results in North American (NA) samples, methods and standards for sex estimation in South Africa (SA) are restricted by incomplete samples and a lack of robust statistical techniques. The purpose of this study was to evaluate accuracies of sex estimation in the postcrania of modern South Africans using multivariate statistics and to compare pattern expression of sexual dimorphism in black, white and coloured groups. The study included analysing the skeletons of a total of 360 SA black, white and coloured individuals and the data of 240 NA black and white individuals (equal sex and ancestry). Sympercents expressed sexual dimorphism and where compared in the three SA groups and with the NA individuals. The creation of different bone models and a variety of multivariate models revealed the potential of multivariate techniques. Comparisons of linear discriminant analysis (LDA), flexible discriminant analysis (FDA) and logistic regression indicated which model provided the greatest discriminatory power between sex and sex-ancestry groups in SA. Among the SA groups coloureds were the most sexually dimorphic; however, overall NA individual showed the greatest differences between the sexes. Multivariate classification accuracies using bone models (various measurements from individual bones) ranged between 75% and 91%, whereas classification accuracies using multivariate subsets (combinations of measurements from different bones) ranged from 85% to 98%. When classifying into sex and ancestry, a multivariate subset using eight measurements achieved classification accuracies of up to 80%. Overall FDA achieved the best results, whereas logistic regression achieved the lowest results for both bone models and multivariate subsets. Postcranial bones achieve comparable classification accuracies to the pelvis and higher accuracies than metric or morphological techniques using the cranium in SA. Large differences in sexual dimorphism between NA and SA warrant the creation of population-specific standards and custom databases for SA. / Dissertation (MSc)--University of Pretoria, 2015. / Anatomy / MSc / Unrestricted

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Anterior cruciate knee ligament injuries are common and well known, especially amongst athletes.These injuries often require surgeries and long rehabilitation programs, and can lead to functionloss and re-injuries (Marshall et al., 1977). This work aims to explore the possibility of applyingsupervised classification on knee functionality, using different types of models, and testing differentdivisions of classes. The data used is gathered through a performance test, where individualsperform one-leg hops with motion sensors attached to their bodies. The obtained data representsthe position over time, and is considered functional data.With functional data analysis (FDA), a process can be analysed as a continuous function of time,instead of being reduced to finite data points. FDA includes many useful tools, but also somechallenges. A functional observation can for example be differentiated, a handy tool not found inthe multivariate tool-box. The speed, and acceleration, can then be calculated from the obtaineddata. How to define "similarity" is, on the other hand, not as obvious as with points. In this work,an FDA-approach is taken on classifying knee kinematic data, from a long-term follow-up studyon knee ligament injuries.This work studies kernel functional classifiers, and k-nearest neighbours models, and performssignificance tests on the model accuracy, using re-sampling methods. Additionally, depending onhow similarity is defined, the models can distinguish different features of the data. Attempts atutilising more information through incorporation of ensemble-methods, does not exceed the singlemodels it is created from. Further, it is shown that classification on optimised sub-domains, canbe superior to classifiers using the full domain, in terms of predictive power. / Främre korsbandsskador är vanliga och välkända skador, speciellt bland idrottsutövare. Skadornakräver ofta operationer och långa rehabiliteringsprogram, och kan leda till funktionell nedsättningoch återskador (Marshall et al., 1977). Målet med det här arbetet är att utforska möjligheten attklassificera knän utifrån funktionalitet, där utfallet är känt. Detta genom att använda olika typerav modeller, och genom att testa olika indelningar av grupper. Datat som används är insamlatunder ett prestandatest, där personer hoppat på ett ben med rörelsesensorer på kroppen. Deninsamlade datan representerar position över tid, och betraktas som funktionell data.Med funktionell dataanalys (FDA) kan en process analyseras som en kontinuerlig funktion av tid,istället för att reduceras till ett ändligt antal datapunkter. FDA innehåller många användbaraverktyg, men även utmaningar. En funktionell observation kan till exempel deriveras, ett händigtverktyg som inte återfinns i den multivariata verktygslådan. Hastigheten och accelerationen kandå beräknas utifrån den insamlade datan. Hur "likhet" är definierat, å andra sidan, är inte likauppenbart som med punkt-data. I det här arbetet används FDA för att klassificera knärörelsedatafrån en långtidsuppföljningsstudie av främre korsbandsskador.I detta arbete studeras både funktionella kärnklassificerare och k-närmsta grannar-metoder, och ut-för signifikanstest av modellträffsäkerheten genom omprovtagning. Vidare kan modellerna urskiljaolika egenskaper i datat, beroende på hur närhet definieras. Ensemblemetoder används i ett försökatt nyttja mer av informationen, men lyckas inte överträffa någon av de enskilda modellerna somutgör ensemblen. Vidare så visas också att klassificering på optimerade deldefinitionsmängder kange en högre förklaringskraft än klassificerare som använder hela definitionsmängden.

Bakgrund och problemformulering: Plattformsstrategier har blivit ett allt vanligare fenomen och i dagsläget är flera av världens största företag plattformsföretag. Digitala plattformar för beställning och leverans av mat är en typ av plattformar som ökat markant de senaste åren, speciellt i och med covid-19 pandemin då restaurangbranschen fick helt nya förutsättningar. Vi har funnit en kunskapslucka gällande restaurangers perspektiv och vilka risker som följer med att verka på digitala matleveransplattformar, samt en avsaknad av forskning kring hur dessa risker hanteras.  Syfte och forskningsfrågor: Syftet med denna studie är att bidra med kunskap och förståelse kring fenomenet plattformstrategi och hur det är att som säljare befinna sig på en plattform, genom att mer specifikt undersöka de risker restauranger som verkar på digitala matleveransplattformar upplever, samt vilka metoder de använder sig utav för att minimera eller eliminera dessa.  • Vilka risker medför det för restauranger att verka på digitala plattformar gällande matleverans?  • Vilka metoder använder sig restauranger av för att minimera eller eliminera de risker de upplever på digitala matleveransplattformar?  Resultat: Resultatet visar att de risker restauranger utsätts för då de verkar på digitala matleveransplattformar är försämrad kundkontakt, förlorad kundbas, begränsad differentiering vid exponering på plattform, påverkan på produktkvalitet samt att en felaktig bild förmedlas till kund. De metoder som restaurangerna nyttjar för att motverka dessa risker är att hota med att lämna eller ej ansluta verksamhetsenheter, skapa större marknadsandel på plattform, verka via fler säljkanaler, verka på fler plattformar, nyttja information från andra parter vid förhandling med plattform, kollektiv handling vid skapande av egen säljkanal, kollektiv avtalsförhandling med plattform och marknadsföring av egen säljkanal via plattform.  Kunskapsbidrag: Denna studie har genom att studera företag som verkar på digitala matleveransplattformar lyft deras perspektiv kring risker som uppstår då de verkar på dessa samt metoder för att motverka riskerna, vilket bidrar till att fylla den identifierade kunskapsluckan. Genom att studera en specifik bransch, bidrar denna studie ytterligare till den kunskapslucka som identifierats. Resultatet visar nya risker och strategier men bekräftar även vissa som förekommer i tidigare litteratur. / Background and formulation of problem: Platform strategy has become a more common phenomenon and many of today’s biggest companies are platforms. Digital platforms that are used for order and delivery of food are one platform type that have increased significantly during these last years, especially due to covid-19 which created challenging conditions for the restaurant industry. We have found a lack of knowledge when it comes to the perspective of restaurants and risks that arise from operating on a digital food delivery platform and how these are handled.  Purpose: The purpose of this study is to contribute with knowledge and understanding of the phenomenon platform strategy and the experience of companies operating on platform by more specifically explore perceived risks, by the restaurants, that arise when operating on a digital food delivery platform and how these can be minimized or eliminated.  What risks arise for restaurants when operating on digital food delivery platforms?  What methods are used by restaurants to minimize or eliminate risks while operating on a digital food delivery platform?  Result: Risks that have been identified in this study are worsened customer contact, lost customer base, limited possibilities to differentiate when presented on platforms, impact on the quality of products and the wrong picture gets painted to the customer. The methods that the restaurants use to counteract these risks are threaten to leave or not let business units join, create a bigger market share on the platform, participate on more sales channels, participate on more platforms, use information from other parties when negotiating with platform, collective actions to create their own sales channel, collective actions when negotiating with platform and marketing of their own sales channels via the platform.  The study's contribution of knowledge: By studying companies operating on digital food delivery platform, this study has shed light on their perspective on risks that arise from operating on a digital platform and methods used to minimize these risks, which contribute to fill the gap of knowledge that has previously been identified. Also, by studying a specific industry, which has not been done before, this study has contributed further to the knowledge within this field. The result of this study shows both strategies and methods that have and have not previously been identified in the literature.

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Made available in DSpace on 2016-07-01T11:59:28Z (GMT). No. of bitstreams: 2 license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) 4.pdf: 2145558 bytes, checksum: 50549f6c199193ece4951dbb22851f56 (MD5) Previous issue date: 2015 / Made available in DSpace on 2016-07-21T14:39:34Z (GMT). No. of bitstreams: 2 4.pdf: 2145558 bytes, checksum: 50549f6c199193ece4951dbb22851f56 (MD5) license.txt: 1748 bytes, checksum: 8a4605be74aa9ea9d79846c1fba20a33 (MD5) Previous issue date: 2015 / Fundação Oswaldo Cruz. Instituto de Tecnologia em Fármacos/Farmanguinhos. Rio de Janeiro, RJ, Brasil. / Os sistemas de liberação transdérmica (SLT) representam atualmente uma via alternativa para a administração de fármacos por difusão passiva através da pele. Os SLT são capazes de contornar inconvenientes, como interações com alimentos e metabolismo de primeira passagem, e de substituir esquemas de doses repetidas, aumentando a adesão do paciente ao tratamento. Entretanto, não há pela Agência Nacional de Vigilância Sanitária (ANVISA) uma regulamentação específica que oriente quanto a exigências para pesquisa, desenvolvimento e registro desses medicamentos, contemplando ensaios e parâmetros definidos na avaliação de segurança e eficácia desses dispositivos. Sendo assim, esta dissertação objetiva realizar um levantamento e comparar as exigências regulatórias utilizadas para obtenção de registro dos SLT nas três principais agências, European Medicines Agency (EMA), Food and Drug Administration (FDA) e ANVISA. Adicionalmente, objetiva realizar uma análise das técnicas que vêm sendo mais vastamente empregadas nos ensaios in vitro de permeação pela comunidade científica, podendo nortear a proposta de uma metodologia harmonizada, inexistente até o momento. A definição dos parâmetros empregados na realização de tais testes é fundamental para o aumento na confiabilidade do método e simulação de biodisponibilidade in vitro, como alternativa aos testes in vivo. A partir do resultado obtido com a pesquisa concernente aos aspectos regulatórios, foi possível identificar duas diretrizes do EMA, dois guias do FDA e testes específicos para os SLT descritos na USP, como fontes suficientes na construção de uma legislação específica voltada a esses dispositivos. Com relação aos testes in vitro de permeação, dois guias da Organização para Cooperação Econômica e Desenvolvimento (OECD) e a análise da prática científica nesses ensaios, possibilitaram a realização de uma proposta para a definição dos parâmetros a serem empregados. / The transdermal drug delivery systems (TDDS) current presents an alternative for drug administration by passive diffusion throughout the skin. The TDDS are capable to avoid inconvenients, as food interactions and first pass metabolism, and to replace repetitive dose scheme, increasing patients adhesion on treatment. However, there is no specific regulation by Agência Nacional de Vigilância Sanitária (ANVISA) to guide for requirements regarding research, development and registration for this drugs, including assay and defined parameters on evaluation of safety and efficacy of these devices. So, the main objective of this work is to identify and to compare the regulatory requirements for TDDS regulatory approval of three most important agencies, European Medicines Agency (EMA), Food and Drug Administration (FDA) and ANVISA. In addition, this work aims to study the must employed techniques on in vitro permeation tests by scientific community to guide the development of an harmonized methodology, which does not exist until now. The parameters definition to be applied on these tests are essential to increase method reliability of in vitro bioavailability simulation, as an alternative for in vivo tests. With results obtained after searching about regulatory aspects, it was possible to identify two EMA guidelines, two FDA guides and specific tests related to TDDS on USP, as suficient sources for specific regulation construction focused on these devices. About in vitro permeation tests, two OECD (Organization for Economic Co-operation and Development) guides and the analysis of scientific practice on these tests, allowed a proposal definition for parameters to be employed.