... one meeting in one medical specialty, and we classified studies using only information available in the abstract This might limit the ability to generalize from our findings, and certainly if ... patients, improving efficiency indrug development, possibly reducing the cost of pharmaceuticals [32], and identifying those drugs that are most likely to be clinically useful and of positive ... Decision Randomization Personal societal interest and selfinterest Accept trial VERSUS Randomization Decision Node Decline trial Expected outcomes of usual care Personal, societal interest and selfinterest...
... continue to be underrepresented and that sex differences in responses to drugs continue to go unexamined during drugdevelopment You asked us to investigate FDA’s progress in addressing the inclusion ... Abbreviations DES FDA IND IOM NDA NME OTC PPA Page ii diethylstilbestrol Food andDrug Administration investigational newdrug Institute of Medicine newdrug application new molecular entity over-the-counter ... arrhythmias in women more often than in men.1 Because of potential sex differences in the safety and efficacy of new drugs, it is important to include women and men in all stages of drugdevelopment and...
... 20120404 13/94 INTRODUCTION ON NEWDRUGDEVELOPMENT (INT-S.) CLINICAL PHARMACOLOGY (2) JHGJ/gh 20120404 14/94 INTRODUCTION ON NEWDRUGDEVELOPMENT (INT-S.) INTRODUCTION ON NEWDRUGDEVELOPMENT TABLE ... 34/94 INTRODUCTION ON NEWDRUGDEVELOPMENT (INT-S.) NEW DRUG: PATENT LIFE (3) JHGJ/gh 20120404 35/94 INTRODUCTION ON NEWDRUGDEVELOPMENT (INT-S.) INTRODUCTION ON NEWDRUGDEVELOPMENT TABLE OF ... 20/94 INTRODUCTION ON NEWDRUGDEVELOPMENT (INT-S.) JHGJ/gh 20120404 21/94 INTRODUCTION ON NEWDRUGDEVELOPMENT (INT-S.) DEVELOPMENT OF A NEWDRUG (2) • Synthesis of the molecule • Studies in animals...
... R&D for NewDrug Introductions in the 1990s,” forthcoming in Pharmco-Economics, 2002; For earlier studies of newdrug introductions in the 1970s and 1980s, see “Returns to R&D on NewDrug Introductions ... costs and returns in the pharmaceutical and biotechnology industries The final section examines recent policy developments andissues surrounding patent lifetime and generic competition in this industry ... Costs, Times and Risks,” 29 Drug Information Journal (1995): 375-384; Kenneth I Kaitin and Joseph A DiMasi, “Measuring the Pace of NewDrugDevelopmentin the User Fee Era,” 34 Drug Information...
... organizing in Ukraine We examine the history of women’s organizing in Soviet and post-Soviet Ukraine, and I invite readers along to a “training” seminar on women and leadership as an example of international ... differentiation Examining emerging social programs and welfare reforms is like tracking a moving target, since reforms are a work in progress and policies keep shifting with the changing political landscape ... marginalisation of women in contemporary Ukraine Honing in on differentiating processes reveals that this marginalization and disintegration is anything but natural and inevitable On the other hand, differentiation...
... business In the second case, the information systems development was a new activity in the organization, and the tools and the way of working were introduced and implemented at the beginning In ... professionals in the industry with understanding of the capabilities and features of new ideas and concepts in information systems development, databases, and forthcoming technologies Keeping with ... analysis and design, and software engineering The primary mission of ADR is to be instrumental in the improvement anddevelopment of theory and practice related to information technology and management...
... Finland Hilkka Merisalo-Rantanen, Helsinki School of Economics, Finland Tuure Tuunanen, The University of Auckland, New Zealand Chapter II Understanding Agile Software, Extreme Programming, and ... business, to stay in it and to be the best in the business The system is tailored to the business, not to the company.” The key driver of the development work is the continuously changing and increasingly ... of research in extreme programming and agile modeling This chapter also examines research in agile software development It first presents the details of agility, XP, and AM, including a literature...
... business In the second case, the information systems development was a new activity in the organization, and the tools and the way of working were introduced and implemented at the beginning In ... Howard, D (2003) Swimming around the waterfall: Introducing and using agile developmentin a data centric, traditional software engineering company In Proceedings of 5th International Conference ... practical software engineering experiments In Proceedings of the Third International Conference on Extreme Programming and Agile Processes in Software Engineering, Alghero, Sardinia, Italy Baskerville,...
... structuring one’s thinking and actions) Accordingly, method has two essential functions in ISD: (a) the function that purports certain effects on human thinking (such as augmenting, facilitating, and ... hermeneutic—that is, interpretative—processes (Introna & Whitley, 1997) This has to with mutual understanding, and augmenting and structuring their way of thinking about IS and ISD Methods are just instruments, ... this interaction they have another role and posses certain intellects and even aim to convey certain thinking about IS and ISD As such, methods have their own reasoning mechanism or understanding...
... advance in our thinking about the effect of method in these interplays rather than reducing its meaning to certain aspects and attributes To show how to advance in thinking, we suggest looking beyond ... within another domain by analogical reasoning Reuse is a major underlying motivation for the emergence of the domain engineering discipline Domain engineering supports the notion of a domain, ... studies in information systems MIS Quarterly, 23(1), 67-93 Linell, P., & Thunqvist, D P (2003) Moving inand out of framings: Activity contexts in talks with young unemployed people within a training...
... to the integration of domain models and viewpoints in an academic and educational context rather than proposing ORM and ORC as new modeling tools in an industrial setting Introduction and Background ... constraints specified in the domain model is determined, and (c) the links among the entities in the domain model are matched by corresponding links in the application model In case such corresponding ... Springer Verlag Eckstein, S., Ahlbrecht, P., & Neumann, K (2001) Increasing reusability in information systems development by applying generic methods In Advanced information systems engineering...
... assembly into newand more suitable development methodologies Reuse and Method Engineering Providing support to development methodologies and especially in the field of situational method engineering ... generalized domain modeling method to model active domains in view of an ongoing attempt to achieve integrated domain ontologies underlying the many viewpoints in conceptual modeling In this chapter, ... consider software-based information system development from the reuse perspective As our interest is in method engineering andin software-based information systems, in the following, we discuss proposals...
... the explicit modeling of stakeholders’ perspectives within their social interactions The perspective modeling and analyzing methodology focuses on representing and handling the interactions among ... about method engineering as well as what method engineers in current situational method-engineering proposals (to perform their work, which consists of building and deploying adequate development ... contexts including previous and next criteria Examples are shown in Figure Exploiting reuse-frame refinement relationships may also be interesting with regard to forbidden criteria Indeed, enlarging...
... providing and handling external data and information that will be accessed by the stakeholders Examples are to use consistent checking and version-control mechanisms to maintain the product data integrity, ... solutions include providing suitable trainings based on their perspectives and the job requirements, assisting the critical stakeholder to review the relevant information during certain conflicting ... conflicting perspectives as means to enhancing brainstorming and innovation Third, strategies can be derived to manage the conflicts through influencing stakeholders’ information access and comprehension...
... access to SEP in their new setting Previous research showed that PR IDU bring cultural norms of syringe sharing with them to NYC since most PR IDU in NYC started injecting drugs in Puerto Rico ... continue to inform continued individual and collective risk behaviors among this population in NYC This habitus migration may help explain IDU continued injection and sexual risk in spite of increased ... migrating; and this was associated with higher levels of syringe sharing in NYC [4] Other IDU migration studies have also discussed the interactions between old andnewdrug injection settings...
... naloxone by drug users is a newand innovative approach to reducing opiate-related mortality Currently, in several cities in the United States (US), drug users are being trained in naloxone administration ... tolerance and supply, control your high, injection techniques, aware of risks of mixing drugs, and minimize using alone), and (c) signs of an opiate overdose The naloxone training included information ... health issue and naloxone is increasingly seen as a newand innovative approach to reducing opiate-related mortality b) Extant prescription drug laws In most states, and until recently inNew York,...
... interventions and cloning trates on practical issues, within the context of licensing clinics for testing speciWc inherited conditions and restricting access through guidelines that limit which ... threatened by cloning In the words of the CCNE report, ‘reproductive cloning would inaugurate a new mode of Wliation, an individual born by cloning would be both a descendant and a twin of an adult’ ... associated with a possibly diminished sense of individuality and personal autonomy, belong to the same analysis Ethical issuesin embryo interventions and cloning Perhaps feminist psychoanalytical...