Drinker Biddle and Reath
Drinker Biddle and Reath
Finch G.,Pfizer |
Havel H.,Eli Lilly and Company |
Analoui M.,Livingston Securities |
Barton R.W.,Nanoviricides Inc. |
And 9 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.
PubMed | Novartis, West Pharmaceutical Services, Pfizer, Baxter Healthcare Corporation and Drinker Biddle and Reath
Type: Review | Journal: PDA journal of pharmaceutical science and technology | Year: 2015
Elemental impurities in drug products can arise from a number of different sources and via a number of different means, including the active pharmaceutical ingredient, excipients, the vehicle, and leaching of elemental entities that are present in the drug products manufacturing or packaging systems. Thus, knowledge about the presence, level, and likelihood of leaching of elemental entities in manufacturing and packaging systems is relevant to understanding how these systems contribute to a drug products total elemental impurity burden. To that end, a joint team from the Extractables and Leachables Safety Information Exchange (ELSIE) Consortium and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) has conducted a review of the available literature on elemental entities in pharmaceutically relevant polymers and the presence of these elemental entities in material extracts and/or drug products. This review article contains the information compiled from the available body of literature and considers two questions: (1) What elemental entities are present in the relevant polymers and materials and at what levels are they present? (2) To what extent are these elemental entities leached from these materials under conditions relevant to the manufacturing and storage/distribution of solution drug products? Conclusions drawn from the compiled data are as follows: (1) Elemental entities are present in the materials used to construct packaging and manufacturing systems as these materials either contain these elemental entities as additives or are exposed to elemental entities during their production. (2) Unless the elemental entities are parts of the materials themselves (for example, SiOExtraneous impurities in drug products provide no therapeutic benefit and thus should be known and controlled. Elemental impurities can arise from a number of sources and by a number of means, including the leaching of elemental entities from drug product packaging and manufacturing systems. To understand the extent to which materials used in packaging systems contain elemental entities and the extent to which those entities leach into drug products to become elemental impurities, the Extractables and Leachables Safety Information Exchange (ELSIE) and International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Consortia have jointly performed a literature review on this subject. Using the compiled information, it was concluded that while packaging materials may contain elemental entities, unless those entities are intentional parts of the materials, the amounts of those elemental entities are generally low. Furthermore, generally only a very small fraction of the total available amount of the entity can be leached under conditions that are relevant to packaged drug products. Thus, risk assessment of sources of elemental impurities in drug products that may be related to materials used in pharmaceutical packaging and manufacturing systems can utilize the information and recommendations presented here.
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.
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.