_How to Develop Robust Scale-up Strategies for Complex Injectable
Dosage Forms: From Bench to the Clinics_ provides a comprehensive
roadmap for transitioning complex injectable formulations from the
laboratory to clinical applications. Offering an exploration of
various complex injectables, including liposomal dosage forms,
nanoparticles, and microspheres, this book delves into dosage form
design, excipient selection, stability studies, and optimization
techniques. The book examines manufacturing technologies such as
aseptic processing, sterile filtration, and lyophilization, and their
applications in producing complex injectables. Discussions on quality
control measures, analytical techniques, and quality assurance
practices are provided to ensure consistent quality and purity
throughout the manufacturing process.
Readers will benefit from the expert knowledge and practical insights
shared by industry professionals and leading researchers, including
successful examples of marketed complex injectables. Highlighting best
practices and regulatory requirements, this book offers a
comprehensive overview of the guidelines for the development,
manufacturing, and commercialization of complex injectables. Ideal for
pharmaceutical scientists, formulation developers, and regulatory
professionals, this book is a valuable resource for anyone involved in
the scale-up and commercialization of complex injectable dosage forms.
* Provides comprehensive guidance on scaling-up complex injectables
from lab to clinical applications
* Offers in-depth insights into dosage form design, excipient
selection, and stability studies
* Explores advanced manufacturing technologies and quality control
measures for consistent product quality
* Highlights regulatory requirements and best practices for
compliance with GMP and regulatory submissions
* Includes successful examples and practical insights from industry
experts and leading researchers
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From Bench to the Clinics
Produktdetaljer
ISBN
9780443403675
Publisert
2024
Utgiver
Elsevier S & T
Språk
Product language
Engelsk
Format
Product format
Digital bok
Forfatter