Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical
$ 127.37
Description
Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development by Hector Goicoechea, Márcia Cristina Breitkreitz Estimated delivery 3-12 business days Format Hardcover Condition Brand New Description Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. Publisher Description Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development. Details ISBN 3031315049 ISBN-13 9783031315046 Title Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development Author Hector Goicoechea, Márcia Cristina Breitkreitz Format Hardcover Year 2023 Pages 266 Edition 2023rd Publisher Springer International Publishing AG GE_Item_ID:144431522; About Us Grand Eagle Retail is the ideal place for all your shopping needs! With fast shipping, low prices, friendly service and over 1,000,000 in stock items - you're bound to find what you want, at a price you'll love! Shipping & Delivery Times Shipping is FREE to any address in USA. Please view eBay estimated delivery times at the top of the listing. Deliveries are made by either USPS or Courier. We are unable to deliver faster than stated. International deliveries will take 1-6 weeks. NOTE: We are unable to offer combined shipping for multiple items purchased. This is because our items are shipped from different locations. Returns If you wish to return an item, please consult our Returns Policy as below: Please contact Customer Services and request "Return Authorisation" before you send your item back to us. Unauthorised returns will not be accepted. Returns must be postmarked within 4 business days of authorisation and must be in resellable condition. Returns are shipped at the customer's risk. We cannot take responsibility for items which are lost or damaged in transit. For purchases where a shipping charge was paid, there will be no refund of the original shipping charge. Additional Questions If you have any questions please feel free to Contact Us. Categories Baby Books Electronics Fashion Games Health & Beauty Home, Garden & Pets Movies Music Sports & Outdoors Toys
Seller sent me the wrong book, but the book they sent sounded interesting enough for me to keep it. I still contacted the seller and communication was fast and professional. They apologized for sending me the wrong book and said I could return it for a refund. I told them that I liked the book they sent me and wanted to keep it. They were happy. Told them thank you and happy new year. People make mistakes, but the fact that this seller was quick and professional and apologized made a difference.
The basket is perfectly what I ordered and as listed. It came in the factory packaging and was perfect upon delivery. Thank you postal service lol. The delivery took way longer than listed though, it was listed to come in a week from purchase, but took a whole month. I had some concerns at first, but communication with the company was top notch and they were very professional and answered most of my questions satisfyingly. Just prepare for a longer wait than listed, but I got what I bought lol.
The two new out-of-print books I ordered were exactly as described and shipped promptly. I did ask the seller's support person (an AI chatbot, I think) to be sure to package the items carefully, and "he" said that he'd make that request of the shipping department. I knew this was hooey, and as I expected, the books were shipped in nothing but a padded paper mailer, no other protection. I got lucky, no damage, but don't bother making special requests of this seller.
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