Pharmaceutical drug product development and process optimization: effective use of quality by design
"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 scient...
Gespeichert in:
| Weitere Verfasser: | , , , , |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Burlington, ON, Canada
Apple Academic Press
2020
|
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | "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.)"-- |
| Beschreibung: | 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 -- 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 Ghori -- 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 |
| Beschreibung: | 1 online resource |
| ISBN: | 9780367821678 0367821672 9781000731583 1000731588 9781000731453 1000731456 9781000731323 1000731324 |
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| 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.)"-- | ||
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| 700 | 1 | |a Alruwaili, Nabil K. |4 edt | |
| 700 | 1 | |a Panda, Sunil Kumar |4 edt | |
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Datensatz im Suchindex
| _version_ | 1804181606926123008 |
|---|---|
| adam_txt | |
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| author2 | Beg, Sarwar 1987- Rahman, Mahfoozur 1984- Imam, Syed Sarim Alruwaili, Nabil K. Panda, Sunil Kumar |
| author2_role | edt edt edt edt edt |
| author2_variant | s b sb m r mr s s i ss ssi n k a nk nka s k p sk skp |
| author_facet | Beg, Sarwar 1987- Rahman, Mahfoozur 1984- Imam, Syed Sarim Alruwaili, Nabil K. Panda, Sunil Kumar |
| building | Verbundindex |
| bvnumber | BV046805772 |
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| dewey-full | 615.1/9 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.1/9 |
| dewey-search | 615.1/9 |
| dewey-sort | 3615.1 19 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| discipline_str_mv | Chemie / Pharmazie Medizin |
| format | Electronic eBook |
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| id | DE-604.BV046805772 |
| illustrated | Not Illustrated |
| index_date | 2024-07-03T14:57:28Z |
| indexdate | 2024-07-10T08:54:20Z |
| institution | BVB |
| isbn | 9780367821678 0367821672 9781000731583 1000731588 9781000731453 1000731456 9781000731323 1000731324 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-032214425 |
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| psigel | ZDB-7-TFC |
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| publisher | Apple Academic Press |
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| spelling | Pharmaceutical drug product development and process optimization effective use of quality by design edited by Sarwar Beg, PhD, Mahfoozur Rahman, PhD, Syed Sarim Imam, PhD, Nabil K. Alruwaili, PhD, Majed Al Robaian, PhD, Sunil Kumar Panda, PhD. Burlington, ON, Canada Apple Academic Press 2020 1 online resource txt rdacontent c rdamedia cr rdacarrier 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 -- 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 Ghori -- 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.)"-- MEDICAL / Pharmacology / bisacsh MEDICAL / Pharmacy / bisacsh Drug development Beg, Sarwar 1987- edt Rahman, Mahfoozur 1984- edt Imam, Syed Sarim edt Alruwaili, Nabil K. edt Panda, Sunil Kumar edt Erscheint auch als Druck-Ausgabe 9781771888721 https://www.taylorfrancis.com/books/9780367821678 Verlag URL des Erstveröffentlichers Volltext |
| spellingShingle | Pharmaceutical drug product development and process optimization effective use of quality by design MEDICAL / Pharmacology / bisacsh MEDICAL / Pharmacy / bisacsh Drug development |
| title | Pharmaceutical drug product development and process optimization effective use of quality by design |
| title_auth | Pharmaceutical drug product development and process optimization effective use of quality by design |
| title_exact_search | Pharmaceutical drug product development and process optimization effective use of quality by design |
| title_exact_search_txtP | Pharmaceutical drug product development and process optimization effective use of quality by design |
| title_full | Pharmaceutical drug product development and process optimization effective use of quality by design edited by Sarwar Beg, PhD, Mahfoozur Rahman, PhD, Syed Sarim Imam, PhD, Nabil K. Alruwaili, PhD, Majed Al Robaian, PhD, Sunil Kumar Panda, PhD. |
| title_fullStr | Pharmaceutical drug product development and process optimization effective use of quality by design edited by Sarwar Beg, PhD, Mahfoozur Rahman, PhD, Syed Sarim Imam, PhD, Nabil K. Alruwaili, PhD, Majed Al Robaian, PhD, Sunil Kumar Panda, PhD. |
| title_full_unstemmed | Pharmaceutical drug product development and process optimization effective use of quality by design edited by Sarwar Beg, PhD, Mahfoozur Rahman, PhD, Syed Sarim Imam, PhD, Nabil K. Alruwaili, PhD, Majed Al Robaian, PhD, Sunil Kumar Panda, PhD. |
| title_short | Pharmaceutical drug product development and process optimization |
| title_sort | pharmaceutical drug product development and process optimization effective use of quality by design |
| title_sub | effective use of quality by design |
| topic | MEDICAL / Pharmacology / bisacsh MEDICAL / Pharmacy / bisacsh Drug development |
| topic_facet | MEDICAL / Pharmacology / bisacsh MEDICAL / Pharmacy / bisacsh Drug development |
| url | https://www.taylorfrancis.com/books/9780367821678 |
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