Formulation Tools for Pharmaceutical Development (Woodhead Publishing Series in Biomedicine) - Tapa dura

Sinopsis

Summary: Of key importance to the pharma industry, this book looks at the contribution of the range of new and innovative tools used for preformulation and formulation of medicines which help to optimize pharmaceutical development projects. Such tools also assist with the performance evaluation of the pharmaceutical process which has already been implemented and which is currently being commercialized - thereby allowing any potential gaps to be identified. This information can also be used to perform optimization of processes. These tools can be applied in both basic research and industrial environment. The tools described in this book also permits the evaluation of the proposed formulation which provides data for a better understanding of the process and the product which supports the development of medicines according to recent new strategies of 'Quality by Design' and 'New Strategy for Process Validation Guidelines'. The tools included in this book are: expert systems; artificial intelligence tools, neuro-fuzzy tools, multimedia tools, artificial neural networks, neurofuzzylogic and genetic programming, plus other mathematical tools. This book is extremely topical since the regulatory environment is changing (such as the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the New Guidance of Process Validation - and the use of preformulation tools in the pharmaceutical industry will help in the development of medicines according to Quality by Design and GMP with 21st century principles. About the editor: Dr Johnny Edward Aguilar is Manufacturing Science and Technology and Technical Director in the Vaccines and Diagnostic Division of a major international pharmaceutical company. Dr Johnny Diaz has more than 11 years of experience in the pharmaceutical industry in different areas such as quality control, quality assurance, highly potent compound management, launching, vaccines and diagnostics management and manufacturing science and technology departments in a major international pharmaceutical company in Spain and Australia. He is also Professor in the Masters in Management Business of the Pharmaceutical Industry and in the Program for Specialists in Industrial Pharmacy by the Spanish Government at the Department of Pharmaceutical Technology at the University of Barcelona, Spain. Contents: Introduction; Artificial neural networks technology to model, understand, and optimize drug formulations; ME_expert 2.0: a heuristic decision support system for microemulsions formulation development; Expert system for the development and formulation of push-pull osmotic pump tablets containing poorly water-soluble drugs; SeDeM Diagram: an expert system for preformulation, characterization and optimization of tablets obtained by direct compression; New SeDeM-ODT expert system: an expert system for formulation of orodispersible tablets obtained by direct compression; 3-D cellular automata in computer- aided design of pharmaceutical formulations: mathematical concept and F-CAD software; OXPIRT: Ontology-based eXpert system for Production of a generic Immediate Release Tablet; Optimisation of compression parameters with AI-based mathematical models

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