Generic Biologics As A Tool For Evaluating The Safety And...

1.Background/Statement Of Problem: Generic biologics (otherwise referred to as biosimilars or follow-on biologics), are described by the FDA as biological products that are highly similar to already approved biological products, notwithstanding minor differences in clinically interactive components and for which there are no clinically meaningful differences between the biosimilar and the approved biological products in terms of safety, purity and potency [4]. Biosimilars are copies of approved biologics, whose patent protection has ended and are analogous to a generic version of a chemically derived drug. Generic biologics are however more complicated to develop than a generic version of a chemically derived drug owing to their complex structure and inherent variability [3]. The assessment of bioequivalence as a tool for evaluating the safety and efficacy is based on the fundamental Bioequivalence Assumption that if two drug products are shown to be bioequivalent in average bioavailability, it is assumed they will reach the same therapeutic effect and be used interchangeably [1]. However, characterizing generic versions of small molecules drugs is considerably easier than characterizing biologic drugs due to several key characteristics [3], based on the fact that characteristics of biologics are influenced by: choice of source materials (cell line), production process, purification process and the final pharmaceutical formulation. Differences inShow MoreRelatedtable of proposal target and time scale10137 Words   |  41 Pagesthe SWOT Analysis (Threats and Opportunities) and PEST. As I think it is the most suitable auditors in making a research for PFIZER external situation. SWOT ANALYSIS www.google/image.com Based on Marketing notes books, SWOT analysis is a tool for auditing an organization and its environment. It is the first stage of planning and helps marketers to focus on key issues. SWOT analysis is a very short analysis and it is very easy to understand. SWOT stands for strength, weaknesses, opportunitiesRead MorePharmaceutical Price Controls in the Oecd Countries47662 Words   |  191 Pagesthat consumers would benefit both from technological breakthroughs and the competition that further innovation generates. The United States also relies on a strong generic pharmaceutical industry to create added competitive pressure to lower drug prices. Recent action by the Administration and Congress has accelerated the flow of generic medicines to the market for precisely that reason. By contrast, in the Organization for Economic Cooperation and Development (OECD) countries studied in this reportRead MoreGsk Annual Report 2010135604 Words   |  543 Pagessubstantially re-engineered GSKâ €™s business through major restructuring and a more rigorous approach to capital allocation. The effects of these changes in 2010 were masked to some degree by speciï ¬ c events. Reported sales, for example, were impacted by generic competition to Valtrex, and reduced sales from Avandia and pandemic related products. Meanwhile earnings were impacted by the signiï ¬ cant charge we took to help resolve long-standing legal matters. This belies the good progress we have made to executeRead MoreCase Study148348 Words   |  594 PagesIntroducing Strategy The Environment Strategic Capabilities Strategic Purpose Culture and Strategy Business Strategy Corporate Strategy and Diversification International Strategy Innovation and Entrepreneurship Mergers, Acquisitions and Alliances Evaluating Strategies Strategy Development Processes Organising for Success Leadership and Strategic Change The Practice of Strategy Pages 30 37 47 59 69 79 88 99 108 115 122 132 144 150 162 Case Teaching Notes The LEGO Group: Working with StrategyRead MoreProject Mgmt296381 Words   |  1186 Pagesscope 5.3 Creating a WBS 5.4 Tools and techniques 6.1 Define activities 9.1.2. Responsibility matrixes 10.1 Communication planning (.2.3.4) [App. G-4] Chapter 12 Outsourcing 12.1.1 Procurement requirements [G.8] 12.1.2.3 Contract types 9.4.2.3 Conflict management 12.2.7 The art of negotiating 12.2.3.5 Change requests Chapter 13 Monitoring Progress Chapter 5 Estimating Times and Costs 6.4 Activity duration estimates (.3) 6.4.2 Estimating tools (.1.3.4) 6.3.1 Identifying resourcesRead MoreMedicare Policy Analysis447966 Words   |  1792 Pagescov21 erage shall notify enrollees of the change at least 90 days 22 before the change takes effect (or such shorter period of rmajette on DSK29S0YB1PROD with BILLS 23 time in cases where the change is necessary to ensure the 24 health and safety of enrollees). †¢HR 3962 IH VerDate Nov 24 2008 12:56 Oct 30, 2009 Jkt 089200 PO 00000 Frm 00102 Fmt 6652 Sfmt 6201 E:\BILLS\H3962.IH H3962 103 3 Subtitle C—Standards Guaranteeing Access to Essential Benefits