Associated and polymerically stabilized dispersions

Our objective is to elucidate the relationships among interparticle forces, microstructure, and rheological properties for concentrated colloidal dispersions and associative polymer solutions. Here we address stable dispersions of spheres bearing grafted polymer chains and solutions of polymer with water soluble backbones modified by the addition of terminal hydrophobes. Non-equilibrium statistical mechanics, combined with treatments of micelles and brushes from the polymer physics literature, offers a means for confirming in detail the mechanisms suggested by recent experiments. © 1999 American Institute of Physics.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/87899/2/23_1.pd

How farm people accept new ideas

Some farmers will try any new idea that comes along, while others will accept an idea only after it is proven in their neighborhood. A major concern of agricultural leaders is that of narrowing the time gap between the early and late adoptions of recommended practices. Some new ideas and practices are accepted quickly and with little apparent effort, while others re accepted only after years of effort on the part of agencies and leaders working with rural people.https://lib.dr.iastate.edu/specialreports/1012/thumbnail.jp

Quality by Design: Concepts for ANDAs

Quality by design is an essential part of the modern approach to pharmaceutical quality. There is much confusion among pharmaceutical scientists in generic drug industry about the appropriate element and terminology of quality by design. This paper discusses quality by design for generic drugs and presents a summary of the key terminology. The elements of quality by design are examined and a consistent nomenclature for quality by design, critical quality attribute, critical process parameter, critical material attribute, and control strategy is proposed. Agreement on these key concepts will allow discussion of the application of these concepts to abbreviated new drug applications to progress

FDA Critical Path Initiatives: Opportunities for Generic Drug Development

FDA’s critical path initiative documents have focused on the challenges involved in the development of new drugs. Some of the focus areas identified apply equally to the production of generic drugs. However, there are scientific challenges unique to the development of generic drugs as well. In May 2007, FDA released a document “Critical Path Opportunities for Generic Drugs” that identified some of the specific challenges in the development of generic drugs. The key steps in generic product development are usually characterization of the reference product, design of a pharmaceutically equivalent and bioequivalent product, design of a consistent manufacturing process and conduct of the pivotal bioequivalence study. There are several areas of opportunity where scientific progress could accelerate the development and approval of generic products and expand the range of products for which generic versions are available, while maintaining high standards for quality, safety, and efficacy. These areas include the use of quality by design to develop bioequivalent products, more efficient bioequivalence methods for systemically acting drugs (expansion of BCS waivers, highly variable drugs), and development of new bioequivalence methods for locally acting drugs

How farm people accept new ideas

Some farmers will try any new idea that comes along, while others will accept an idea only after it is proven in their neighborhood. A major concern of agricultural leaders is that of narrowing the time gap between the early and late adoptions of recommended practices. Some new ideas and practices are accepted quickly and with little apparent effort, while others re accepted only after years of effort on the part of agencies and leaders working with rural people.</p