| Contents |
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 |
| Abstract |
"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.)"-- Provided by publisher. |
| Bibliography note | Includes bibliographical references and index. |
| Access restriction | Available only to authorized users. |
| Technical details | Mode of access: World Wide Web |
| Source of description | Description based on print version record and CIP data provided by publisher; resource not viewed. |
| Issued in other form | Print version: Pharmaceutical drug product development and process optimization Palm Bay, Florida : Apple Academic Press, [2020] 9781771888721 |
| Genre/form | Electronic books. |
| LCCN | 2020005169 |
| ISBN | 9780367821678 (ebook) |
| ISBN | (hardcover) |
