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How to Develop Robust Solid Oral Dosage Forms: From Conception to Post-Approval: Expertise in Pharmaceutical Process Technology

Autor Bhavishya Mittal
en Limba Engleză Paperback – 5 oct 2016
How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips.
By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms.


  • Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more
  • Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin
  • Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues
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Specificații

ISBN-13: 9780128047316
ISBN-10: 0128047313
Pagini: 190
Dimensiuni: 152 x 229 x 14 mm
Greutate: 0.32 kg
Editura: ELSEVIER SCIENCE
Seria Expertise in Pharmaceutical Process Technology


Cuprins

1. Rules of Drug Product Development2. Pharmacokinetics and Preformulation3. Formulation Development4. Pharmaceutical Unit Operations5. Process Development6. Analytical Considerations7. Process Scale-up, Tech-Transfer, and Optimization8. Business Acuity

Recenzii

"Readers will get a good overview of each topic, alongside practical advice and illustrative case studies. Decision trees and reference tables are particularly useful. ... This excellent book provides a great introduction for anyone starting a career in formulation science, and is a perfect starting point for trouble shooting issues throughout the formulation development process." --Emma McConnell, The Pharmaceutical Journal