FDA’s Drug Review Process and the Package Label, (PDF) guidance to pharmaceutical companies for writing FDA-submissions, such as the BLA, NDA, Clinical Study Reports, and Investigator’s Brochures. The ebook provides guidance to medical writers for drafting FDA-submissions in a way more likely to encourage FDA reviewers to grant approval of
A Concrete Introduction to Analysis, 2nd Edition, (PDF), provides a major reorganization of the prior edition with the aim of making it a much more accessible and comprehensive for college students. The standard, somber approach to teaching modern mathematics with its focus on formal proofs can be discouraging and challenging
Open Innovation and Entrepreneurship, (PDF) combines theoretical perspectives and empirical evidence on open innovation and entrepreneurship as two important ways to help entrepreneurial businesses grow and gain a competitive advantage. Discussing essential issues at the link of entrepreneurship and open innovation, such as creating competitive advantage, enterprise growth, implementation of
Composed of contributions from prominent experts in quantum foundations, this volume offers viewpoints on a number of complex problems through probabilistic, informational, and mathematical perspectives and features novel mathematical models of quantum and subquantum phenomena. Enrich with multi-disciplinary mathematical content, Quantum Foundations, Probability and Information (PDF) includes applications of partial
Education and Public Policy in the European Union, (PDF) fleshes out activities and initiatives in the area of education from across areas of European Union competence in order to emphasize the extent to which education and training have entered the European Community’s policymaking since its creation. Policies are all too