東華大學圖書館 |

語系: 繁體中文

說明(常見問題)

回圖書館首頁

手機版館藏查詢

登入

回首頁

切換: 標籤 | MARC模式 | ISBD

Introduction to quality by design in...

Goicoechea, Hector.

FindBook

Google Book

Amazon

博客來

Introduction to quality by design in pharmaceutical manufacturing and analytical development

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Introduction to quality by design in pharmaceutical manufacturing and analytical development/ edited by Marcia Cristina Breitkreitz, Hector Goicoechea.
其他作者:	Goicoechea, Hector.
出版者:	Cham :Springer International Publishing : : 2023.,
面頁冊數:	x, 266 p. :ill. (some col.), digital ;24 cm.
內容註:	Part 1: Quality by Design (QbD) -- Chapter 1. Pharmaceutical Quality by Design (QbD) overview and major elements -- Chapter 2. Fundamentals of design of experiments and optimization: designs for factor screening and data analysis in pre-response surface methodology -- Chapter 3. Fundamentals of design of experiments and optimization: experimental designs in response surface methodology -- Chapter 4. Fundamentals of design of experiments and optimization: data modeling in response surface methodology -- Chapter 5. Quality by Design in pharmaceutical product and process development -- Chapter 6. A Quality by Design update on nano-drug delivery systems -- Chapter 7. Control strategies of solid dosage forms by PAT tools -- Part 2: Analytical Quality by Design (AQbD) -- Chapter 8. Analytical Quality by Design Fundamentals, Compendial and Regulatory Perspectives -- Chapter 9. Analytical Target Profile (ATP) and Method Operable Design Region (MODR) -- Chapter 10: Quality by Design applications to development of analytical methods for quality control of pharmaceuticals -- Chapter 11. Design of Experiments Applied to the Extraction of Active Compounds.
Contained By:	Springer Nature eBook
標題:	Drugs - Design -
電子資源:	https://doi.org/10.1007/978-3-031-31505-3
ISBN:	9783031315053

Introduction to quality by design in pharmaceutical manufacturing and analytical development
Introduction to quality by design in pharmaceutical manufacturing and analytical development[electronic resource] /edited by Marcia Cristina Breitkreitz, Hector Goicoechea. - Cham :Springer International Publishing :2023. - x, 266 p. :ill. (some col.), digital ;24 cm. - AAPS introductions in the pharmaceutical sciences,102522-8358 ;. - AAPS introductions in the pharmaceutical sciences ;10..

Part 1: Quality by Design (QbD) -- Chapter 1. Pharmaceutical Quality by Design (QbD) overview and major elements -- Chapter 2. Fundamentals of design of experiments and optimization: designs for factor screening and data analysis in pre-response surface methodology -- Chapter 3. Fundamentals of design of experiments and optimization: experimental designs in response surface methodology -- Chapter 4. Fundamentals of design of experiments and optimization: data modeling in response surface methodology -- Chapter 5. Quality by Design in pharmaceutical product and process development -- Chapter 6. A Quality by Design update on nano-drug delivery systems -- Chapter 7. Control strategies of solid dosage forms by PAT tools -- Part 2: Analytical Quality by Design (AQbD) -- Chapter 8. Analytical Quality by Design Fundamentals, Compendial and Regulatory Perspectives -- Chapter 9. Analytical Target Profile (ATP) and Method Operable Design Region (MODR) -- Chapter 10: Quality by Design applications to development of analytical methods for quality control of pharmaceuticals -- Chapter 11. Design of Experiments Applied to the Extraction of Active Compounds.

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.

ISBN: 9783031315053

Standard No.: 10.1007/978-3-031-31505-3doiSubjects--Topical Terms:

3662581
Drugs
--Design

LC Class. No.: RS420

Dewey Class. No.: 615.19

Introduction to quality by design in pharmaceutical manufacturing and analytical development
LDR:04236nmm a2200337 a 4500 001 2332585
003 DE-He213
005 20230713091752.0
006 m d
007 cr nn 008maaau
008 240402s2023 sz s 0 eng d
020 $a 9783031315053 $q (electronic bk.)
020 $a 9783031315046 $q (paper)
024 7 $a 10.1007/978-3-031-31505-3 $2 doi
035 $a 978-3-031-31505-3
040 $a GP $c GP
041 0 $a eng
050 4 $a RS420
072 7 $a MMG $2 bicssc
072 7 $a MED071000 $2 bisacsh
072 7 $a MKG $2 thema
082 0 4 $a 615.19 $2 23
090 $a RS420 $b .I61 2023
245 0 0 $a Introduction to quality by design in pharmaceutical manufacturing and analytical development $h [electronic resource] / $c edited by Marcia Cristina Breitkreitz, Hector Goicoechea.
260 $a Cham : $b Springer International Publishing : $b Imprint: Springer, $c 2023.
300 $a x, 266 p. : $b ill. (some col.), digital ; $c 24 cm.
490 1 $a AAPS introductions in the pharmaceutical sciences, $x 2522-8358 ; $v 10
505 0 $a Part 1: Quality by Design (QbD) -- Chapter 1. Pharmaceutical Quality by Design (QbD) overview and major elements -- Chapter 2. Fundamentals of design of experiments and optimization: designs for factor screening and data analysis in pre-response surface methodology -- Chapter 3. Fundamentals of design of experiments and optimization: experimental designs in response surface methodology -- Chapter 4. Fundamentals of design of experiments and optimization: data modeling in response surface methodology -- Chapter 5. Quality by Design in pharmaceutical product and process development -- Chapter 6. A Quality by Design update on nano-drug delivery systems -- Chapter 7. Control strategies of solid dosage forms by PAT tools -- Part 2: Analytical Quality by Design (AQbD) -- Chapter 8. Analytical Quality by Design Fundamentals, Compendial and Regulatory Perspectives -- Chapter 9. Analytical Target Profile (ATP) and Method Operable Design Region (MODR) -- Chapter 10: Quality by Design applications to development of analytical methods for quality control of pharmaceuticals -- Chapter 11. Design of Experiments Applied to the Extraction of Active Compounds.
520 $a 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.
650 0 $a Drugs $x Design $x Quality control. $3 3662581
650 0 $a Pharmaceutical industry $x Quality control. $3 661541
650 1 4 $a Pharmacology. $3 634543
650 2 4 $a Pharmaceutics. $3 3538434
700 1 $a Goicoechea, Hector. $3 3662580
700 1 $a Breitkreitz, Marcia Cristina. $3 3662579
710 2 $a SpringerLink (Online service) $3 836513
773 0 $t Springer Nature eBook
830 0 $a AAPS introductions in the pharmaceutical sciences ; $v 10. $3 3633347
856 4 0 $u https://doi.org/10.1007/978-3-031-31505-3
950 $a Biomedical and Life Sciences (SpringerNature-11642)