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New Drug Approval Process
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step
New Drug Approval Process
Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term foll.
The Crisis
The Crisis, founded by W.E.B. Du Bois as the official publication of the NAACP, is a journal of civil rights, history, politics, and culture and seeks to educate and challenge its readers about issues that continue to plague African Americans and other communities of color. For nearly 100 years, The Crisis has been the magazine of opinion and thought leaders, decision makers, peacemakers and justice seekers. It has chronicled, informed, educated, entertained and, in many instances, set the economic, political and social agenda for our nation and its multi-ethnic citizens.
Mathematical Statistics With Applications
Mathematical statistics typically represents one of the most difficult challenges in statistics, particularly for those with more applied, rather than mathematical, interests and backgrounds. Most textbooks on the subject provide little or no review of the advanced calculus topics upon which much of mathematical statistics relies and furthermore contain material that is wholly theoretical, thus presenting even greater challenges to those interested in applying advanced statistics to a specific area. Mathematical Statistics with Applications presents the background concepts and builds the technical sophistication needed to move on to more advanced studies in multivariate analysis, decision th...
