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Añadir al carritoTaschenbuch. Condición: Neu. Pharmaceutical Suspensions | From Formulation Development to Manufacturing | Alok K. Kulshreshtha (u. a.) | Taschenbuch | xvi | Englisch | 2014 | Springer US | EAN 9781489984173 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.
Idioma: Inglés
Publicado por Springer New York, Springer New York, 2009
ISBN 10: 1441910867 ISBN 13: 9781441910868
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Añadir al carritoBuch. Condición: Neu. Druck auf Anfrage Neuware - Printed after ordering - The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system - poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.
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Publicado por Springer New York, Springer US, 2014
ISBN 10: 1489984178 ISBN 13: 9781489984173
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Añadir al carritoTaschenbuch. Condición: Neu. Druck auf Anfrage Neuware - Printed after ordering - The suspension dosage form has long been used for poorly soluble active ingre- ents for various therapeutic indications. Development of stable suspensions over the shelf life of the drug product continues to be a challenge on many fronts. A good understanding of the fundamentals of disperse systems is essential in the development of a suitable pharmaceutical suspension. The development of a s- pension dosage form follows a very complicated path. The selection of the proper excipients (surfactants, viscosity imparting agents etc.) is important. The particle size distribution in the finished drug product dosage form is a critical parameter that significantly impacts the bioavailability and pharmacokinetics of the product. Appropriate analytical methodologies and instruments (chromatographs, visco- ters, particle size analyzers, etc.) must be utilized to properly characterize the s- pension formulation. The development process continues with a successful scale-up of the manufacturing process. Regulatory agencies around the world require cli- cal trials to establish the safety and efficacy of the drug product. All of this devel- ment work should culminate into a regulatory filing in accordance with the regulatory guidelines. Pharmaceutical Suspensions, From Formulation Development to Manufacturing, in its organization, follows the development approach used widely in the pharmaceutical industry. The primary focus of this book is on the classical disperse system - poorly soluble active pharmaceutical ingredients s- pended in a suitable vehicle.
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Añadir al carritoBuch. Condición: Neu. Pharmaceutical Suspensions | From Formulation Development to Manufacturing | Alok K. Kulshreshtha (u. a.) | Buch | xvi | Englisch | 2009 | Copernicus | EAN 9781441910868 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu Print on Demand.