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Finch G.,Pfizer | Havel H.,Eli Lilly and Company | Barton R.W.,Nanoviricides Inc. | Diwan A.R.,Nanoviricides Inc. | And 8 more authors.
AAPS Journal | Year: 2014

The use of nanotechnology in medicine holds great promise for revolutionizing a variety of therapies. The past decade witnessed dramatic advancements in scientific research in nanomedicines, although significant challenges still exist in nanomedicine design, characterization, development, and manufacturing. In March 2013, a two-day symposium "Nanomedicines: Charting a Roadmap to Commercialization," sponsored and organized by the Nanomedicines Alliance, was held to facilitate better understanding of the current science and investigative approaches and to identify and discuss challenges and knowledge gaps in nanomedicine development programs. The symposium provided a forum for constructive dialogue among key stakeholders in five distinct areas: nanomedicine design, preclinical pharmacology, toxicology, CMC (chemistry, manufacturing, and control), and clinical development. In this meeting synopsis, we highlight key points from plenary presentations and focus on discussions and recommendations from breakout sessions of the symposium. © 2014 American Association of Pharmaceutical Scientists.

Mullin L.,Albany State University | Raynolds J.,Drinker Biddle and Reath
Studies in Computational Intelligence | Year: 2014

Understanding the layout of data and the accessing of that data is paramount to the optimal performance of an algorithm on one or many processors. This paper addresses the need for efficient tools to implement and carry out tensor based computations for scientific and engineering applications. In particular, we focus on certain ubiquitous operations such as outer products of arbitrary multi-dimensional arrays and matrix Kronecker products. We advocate an algebraic methodology based on A Mathematics of Arrays (MoA) and the ψ-Calculus, in which, any array based computer language (such as MATLAB) would be augmented to achieve optimal performance for the computation of multiple outer products. In this approach, an Operational Normal Form (ONF), which specifies the most efficient implementation in terms of starts, stops, and strides is mathematically derived given specific details of the processor/memory hierarchy. The vision of this research is the creation of a system in which the application scientist or engineer can use a functional subset of his/her favorite language and, in so doing, have the ability to generate code with high efficiency and compiler-like optimizations. © 2014 Springer International Publishing Switzerland.

Evans C.,Catalent Pharma Solutions | Cipolla D.,Aradigm Inc. | Chesworth T.,Astrazeneca | Agurell E.,Swedish Medical Products Agency | And 22 more authors.
Journal of Aerosol Medicine and Pulmonary Drug Delivery | Year: 2012

The purpose of this article is to document the discussions at the 2010 European Workshop on Equivalence Determinations for Orally Inhaled Drugs for Local Action, cohosted by the International Society for Aerosols in Medicine (ISAM) and the International Pharmaceutical Consortium on Regulation and Science (IPAC-RS). The article summarizes current regulatory approaches in Europe, the United States, and Canada, and presents points of consensus as well as ongoing debate in the four major areas: in vitro testing, pharmacokinetic and pharmacodynamic studies, and device similarity. Specific issues in need of further research and discussion are also identified. © 2012 Mary Ann Liebert, Inc.

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