Pharmaceutical Drug Product Development and Process Optimization: Effective Use of Quality by Design, 1st Edition (Hardback) book cover

Pharmaceutical Drug Product Development and Process Optimization

Effective Use of Quality by Design, 1st Edition

Edited by Sarwar Beg, Sunil Kumar Panda, Mahfoozur Rahman, Syed Sarim Imam

Apple Academic Press

376 pages | 18 Color Illus. | 31 B/W Illus.

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Hardback: 9781771888721
pub: 2020-04-20
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Description

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.

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Table of Contents

1. Introduction to Pharmaceutical Product Development

Rahul Shukla, Mayank Handa, and Vishwas P. Pardhi

2. Systematic Product and Process Development Tools in Life Cycle Management

Mohamad Taleuzzaman et al.

3. Recent Advances in the Development of Solid Oral Dosage Forms

Mohammed Tahir Ansari et al.

4. 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 et al.

6. Recent Advances in the Development of Semisolid Dosage Forms

Rabinarayan Parhi

7. Recent Advancements in Transdermal Drug Delivery Systems

Mohammed Asadullah Jahangir, Abdul Muheem, and Syed Sarim Imam

8. Recent Advances in the Formulation Development of Inhalational Dosage Forms

A. A. Sallam

9. QBD-Based Novel Ocular Drug Delivery Systems

Mohammed Jafar, Syed Sarim Imamb, and Syed Azizullah Ghori

10. Recent Advances in the Development of Nanopharmaceutical Products

Rahul Shukla et al.

11. Recent Advances in the Development of Nanoparticles for Oral Delivery

Md. Rizwanullah et al.

 

About the Editors

Sarwar Beg, PhD, is currently serving as Assistant Professor of Pharmaceutics & Biopharmaceutics at the School of Pharmaceutical Education and Research, Jamia Hamdard University, New Delhi, India

Sunil Kumar Panda, PhD, serves as Director of Research & Development at Menovo Pharmaceuticals (Shanghai stock exchange enlisted company) in the People’s Republic of China.

Mahfoozur Rahman, PhD, is an Assistant Professor at the Department of Pharmaceutical Sciences, Faculty of Health Science, Sam Higginbottom University of Agriculture, Technology & Sciences (SHUATS), Allahabad, India.

Syed Sarim Imam, PhD, is an Associate Professor at the College of Pharmacy, King Saud University, Saudi Arabia.

Subject Categories

BISAC Subject Codes/Headings:
BUS070130
BUSINESS & ECONOMICS / Industries / Pharmaceutical & Biotechnology
MED071000
MEDICAL / Pharmacology
MED072000
MEDICAL / Pharmacy
SCI000000
SCIENCE / General