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Bücher Englische Bücher Wissen & Bildung Naturwissenschaft, Medizin, Informatik, Technik Medizin Pharmazie Pharmaceutical Suspensions
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Beschreibung
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. 160,49 €
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Technische Daten
Erscheinungsdatum
28.11.2014
Sprache
Englisch
EAN
9781489984173
Herausgeber
Springer US
Sonderedition
Nein
Seitenanzahl
328
Auflage
1
Einbandart
Broschiert
Buch Untertitel
From Formulation Development to Manufacturing
Schlagwörter
Formulation, Kulshreshtha, Singh, Suspentions, Wall, clinical trial, development, drug, kinetics, manufacturing, pharmaceutical, pharmacokinetics, research
Thema-Inhalt
MKG - Pharmakologie
Höhe
235 mm
Breite
15.5 cm
Transparenz & Sicherheit
Hersteller: Humana, Europaplatz 3, Heidelberg, Deutschland, 69115, ProductSafety@springernature.com, Springer Nature Customer Service Center GmbH
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