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Pharmaceutical drug product developm...

Beg, Sarwar, (1987-)

Pharmaceutical drug product development and process optimization :effective use of quality by design /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Pharmaceutical drug product development and process optimization :/ edited by Sarwar Beg ... [et al.].
其他題名:	effective use of quality by design /
其他作者:	Beg, Sarwar,
出版者:	Palm Bay, Fla. :Apple Academic Press, : c2020.,
面頁冊數:	xxvii, 353 p. :ill. (some col.),col. ports. ; : 24 cm.;
提要註:	"Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume, Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design, addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost-effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery. Providing an abundance of knowledge, this volume will be valuable for those who are engaged in pharmaceutical product development, including new drugs and generic drug products. Key features Reviews a vast collection of literature on applicability of systematic product development tools Discusses various dosage forms where challenges are very high Provides regulatory guidance related to specific dosage form development Covers the major types of drug products, including enteral, parenteral, and other (including transdermal, inhalation, etc.)"--
標題:	Quality Control. -
ISBN:	9781771888721 (hard) :

Pharmaceutical drug product development and process optimization :effective use of quality by design /
Pharmaceutical drug product development and process optimization :effective use of quality by design /edited by Sarwar Beg ... [et al.]. - Palm Bay, Fla. :Apple Academic Press,c2020. - xxvii, 353 p. :ill. (some col.),col. ports. ;24 cm.

Includes bibliographical references and index.

Introduction to Pharmaceutical Product Development / Rahul Shukla, Mayank Handa, and Vishwas P. Pardhi -- Systematic Product and Process Development Tools in Life Cycle Management / Mohamad Taleuzzaman, Sanjay Chuhan, Sadaf Jamal Gilani, and Syed Sarim Imam -- Recent Advances in the Development of Solid Oral Dosage Forms / Mohammed Tahir Ansari, Farheen Mohd Sami, Mohammad Saquib Hasnain, Shahnaz Majeed, and Sadat Ali -- Recent Advances in the Development of Modified Release Oral Dosage Forms / Goutam Kumar Jena, Ch Niranjan Patra, and Sarwar Beg 5. Recent Advances in the Development of Parenteral Dosage Forms / Abdul Muheem, Sobiya Zafar, Mohammed Asadullah Jahangir, Musarrat Husain Warsi, Syed Sarim Imam, Gaurav Kumar Jain, and Farhan Jalees Ahmad -- Recent Advances in the Development of Semisolid Dosage Forms / Rabinarayan Parhi -- Recent Advancements in Transdermal Drug Delivery Systems / Mohammed Asadullah Jahangir, Abdul Muheem, and Syed Sarim Imam -- Recent Advances in the Formulation Development of Inhalational Dosage Forms / A. A. Sallam -- QBD-Based Novel Ocular Drug Delivery Systems / Mohammed Jafar, Syed Sarim Imam, and Syed Azizullah Ghor -- Recent Advances in the Development of Nanopharmaceutical Products / Rahul Shukla, Ajit Singh, Nidhi Singh, and Dheeraj Kumar -- Recent Advances in the Development of Nanoparticles for Oral Delivery / Md. Rizwanullah, Mohd. Moshahid Alam Rizvi, and Saima Amin

"Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume, Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design, addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost-effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery. Providing an abundance of knowledge, this volume will be valuable for those who are engaged in pharmaceutical product development, including new drugs and generic drug products. Key features Reviews a vast collection of literature on applicability of systematic product development tools Discusses various dosage forms where challenges are very high Provides regulatory guidance related to specific dosage form development Covers the major types of drug products, including enteral, parenteral, and other (including transdermal, inhalation, etc.)"--

ISBN: 9781771888721 (hard) :NT5069

LCCN: 2020005168Subjects--Topical Terms:

217598
Quality Control.

LC Class. No.: RM301.25

Dewey Class. No.: 615.1/9

National Library of Medicine Call No.: QV 745

Pharmaceutical drug product development and process optimization :effective use of quality by design /
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300 $a xxvii, 353 p. : $b ill. (some col.),col. ports. ; $c 24 cm.
504 $a Includes bibliographical references and index.
505 0 $a Introduction to Pharmaceutical Product Development / Rahul Shukla, Mayank Handa, and Vishwas P. Pardhi -- Systematic Product and Process Development Tools in Life Cycle Management / Mohamad Taleuzzaman, Sanjay Chuhan, Sadaf Jamal Gilani, and Syed Sarim Imam -- Recent Advances in the Development of Solid Oral Dosage Forms / Mohammed Tahir Ansari, Farheen Mohd Sami, Mohammad Saquib Hasnain, Shahnaz Majeed, and Sadat Ali -- Recent Advances in the Development of Modified Release Oral Dosage Forms / Goutam Kumar Jena, Ch Niranjan Patra, and Sarwar Beg 5. Recent Advances in the Development of Parenteral Dosage Forms / Abdul Muheem, Sobiya Zafar, Mohammed Asadullah Jahangir, Musarrat Husain Warsi, Syed Sarim Imam, Gaurav Kumar Jain, and Farhan Jalees Ahmad -- Recent Advances in the Development of Semisolid Dosage Forms / Rabinarayan Parhi -- Recent Advancements in Transdermal Drug Delivery Systems / Mohammed Asadullah Jahangir, Abdul Muheem, and Syed Sarim Imam -- Recent Advances in the Formulation Development of Inhalational Dosage Forms / A. A. Sallam -- QBD-Based Novel Ocular Drug Delivery Systems / Mohammed Jafar, Syed Sarim Imam, and Syed Azizullah Ghor -- Recent Advances in the Development of Nanopharmaceutical Products / Rahul Shukla, Ajit Singh, Nidhi Singh, and Dheeraj Kumar -- Recent Advances in the Development of Nanoparticles for Oral Delivery / Md. Rizwanullah, Mohd. Moshahid Alam Rizvi, and Saima Amin
520 $a "Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume, Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design, addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost-effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery. Providing an abundance of knowledge, this volume will be valuable for those who are engaged in pharmaceutical product development, including new drugs and generic drug products. Key features Reviews a vast collection of literature on applicability of systematic product development tools Discusses various dosage forms where challenges are very high Provides regulatory guidance related to specific dosage form development Covers the major types of drug products, including enteral, parenteral, and other (including transdermal, inhalation, etc.)"-- $c Provided by publisher.
650 2 2 $2 96060 $a Quality Control. $3 217598
650 1 2 $a Drug Development. $3 464503
650 0 $2 96060 $a Drug development. $3 232902
700 1 $a Beg, Sarwar, $d 1987- $3 464502