Cantitate/Preț
Produs

Quality by Design for Biopharmaceuticals – Principles and Case Studies: Wiley Series in Biotechnology and Bioengineering

Autor AS Rathore
en Limba Engleză Hardback – 9 iul 2009
This is the first book that explains the underlying concepts of Quality by Design (QbD) and the practical aspects of implementing QbD in biopharmaceutical manufacturing. A systematic approach leads the reader through a process, outlining the understanding of the critical quality attributes of the molecule, the development of the design space to meet the quality attributes, filing of the QbD information in regulatory documents, risk management, and the application of QbD. Complete with real-world case studies, this is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Citește tot Restrânge

Din seria Wiley Series in Biotechnology and Bioengineering

Preț: 90566 lei

Preț vechi: 99522 lei
-9% Nou

Puncte Express: 1358

Preț estimativ în valută:
17332 18004$ 14397£

Carte tipărită la comandă

Livrare economică 03-17 februarie 25

Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9780470282335
ISBN-10: 0470282339
Pagini: 312
Dimensiuni: 156 x 234 x 19 mm
Greutate: 0.59 kg
Editura: Wiley
Seria Wiley Series in Biotechnology and Bioengineering

Locul publicării:Hoboken, United States

Public țintă

Scientists and engineers in R&D, Process Development, Quality Control, Manufacturing and Regulatory departments of the biotech/pharmaceutical industry; Members of worldwide regulatory agencies (FDA, EMEA, Health Canada, etc)

Notă biografică


Cuprins


Descriere

Provides an in-depth understanding of the underlying concepts of Quality by Design (QbD) and the practical aspects of the implementation of QbD in biopharmaceutical manufacturing.