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New Drug Approval Process Volume 190 5th Edition (SIE) | Guarino R.A. | Latest Edition | Taylor & Francis Group (English Medium )
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| 5068-5995 |
The "New Drug Approval Process Volume 190 5th Edition (SIE)" by Guarino R.A. is a comprehensive guide to understanding the complex process of getting a new drug approved for market in the pharmaceutical industry. This latest edition from Taylor & Francis Group provides updated information on the latest regulations, guidelines, and best practices for navigating the drug approval process. This book covers all aspects of drug development and approval, from preclinical studies and clinical trials to regulatory submissions and post-marketing surveillance. It also includes case studies and real-world examples to help readers understand how these processes work in practice. Key topics covered in this book include: - The role of the FDA and other regulatory agencies in drug approval - Preclinical testing and animal studies - Clinical trial design and implementation - Regulatory submissions and approvals - Post-marketing surveillance and pharmacovigilance Whether you are a pharmaceutical professional, researcher, regulator, or student looking to learn more about the drug approval process, this book is an essential resource for understanding the complexities of bringing a new drug to market.
New Drug Approval Process Volume 190 (5th Edition) by Guarino R.A. is a comprehensive and authoritative reference book for understanding the regulatory, clinical, and scientific aspects of drug approval. Published by Taylor & Francis Group, this 2026 hardbound edition is ideal for pharmaceutical professionals, researchers, and postgraduate students.
The book provides a detailed overview of the entire drug development and approval process, including preclinical studies, clinical trials, and regulatory submissions. It explains key procedures such as IND (Investigational New Drug), NDA (New Drug Application), ANDA, and global regulatory frameworks in a structured and practical manner.
One of the major strengths of this book is its focus on international regulatory requirements and harmonization guidelines like ICH. It also covers modern documentation formats such as CTD and eCTD, helping readers understand global submission standards effectively.
This edition includes updated content reflecting current trends in pharmaceutical development, clinical research practices, and regulatory strategies. It also emphasizes real-world application, making it highly useful for professionals involved in drug development, regulatory affairs, and quality assurance.
With 529 pages of detailed and well-organized content, this book serves as both a learning resource and a professional reference. The hardbound format ensures durability, making it suitable for long-term use in institutions, libraries, and industry settings.
Whether you are preparing for exams or working in the pharmaceutical industry, this book is an essential guide to mastering the drug approval process.
| SKU / BOOK Code: | NDAP-V190-5ED-SIE-2026-9781138 |
| Publisher: | Taylor & Francis Group |
| Author: | Guarino R.A. |
| Binding Type: | Hardcover |
| No. of Pages: | 529 |
| ISBN-10: | NA |
| ISBN-13: | NA |
| Edition: | 15th |
| Language: | English Medium |
| Publish Year: | 2026-01 |
| Weight (g): | 600 |
| Product Condition: | New |
| Reading Age: | Above 18 Years |
| Country of Origin: | India |
| Genre: | Medicine & Health Sciences |
| Manufacturer: | Taylor & Francis Group |
| Importer: | Taylor & Francis Group |
| Packer: | Fullfilled by Supplier |
The "New Drug Approval Process Volume 190 5th Edition (SIE)" by Guarino R.A. is a comprehensive guide to understanding the complex process of getting a new drug approved for market in the pharmaceutical industry. This latest edition from Taylor & Francis Group provides updated information on the latest regulations, guidelines, and best practices for navigating the drug approval process. This book covers all aspects of drug development and approval, from preclinical studies and clinical trials to regulatory submissions and post-marketing surveillance. It also includes case studies and real-world examples to help readers understand how these processes work in practice. Key topics covered in this book include: - The role of the FDA and other regulatory agencies in drug approval - Preclinical testing and animal studies - Clinical trial design and implementation - Regulatory submissions and approvals - Post-marketing surveillance and pharmacovigilance Whether you are a pharmaceutical professional, researcher, regulator, or student looking to learn more about the drug approval process, this book is an essential resource for understanding the complexities of bringing a new drug to market.
New Drug Approval Process Volume 190 (5th Edition) by Guarino R.A. is a comprehensive and authoritative reference book for understanding the regulatory, clinical, and scientific aspects of drug approval. Published by Taylor & Francis Group, this 2026 hardbound edition is ideal for pharmaceutical professionals, researchers, and postgraduate students.
The book provides a detailed overview of the entire drug development and approval process, including preclinical studies, clinical trials, and regulatory submissions. It explains key procedures such as IND (Investigational New Drug), NDA (New Drug Application), ANDA, and global regulatory frameworks in a structured and practical manner.
One of the major strengths of this book is its focus on international regulatory requirements and harmonization guidelines like ICH. It also covers modern documentation formats such as CTD and eCTD, helping readers understand global submission standards effectively.
This edition includes updated content reflecting current trends in pharmaceutical development, clinical research practices, and regulatory strategies. It also emphasizes real-world application, making it highly useful for professionals involved in drug development, regulatory affairs, and quality assurance.
With 529 pages of detailed and well-organized content, this book serves as both a learning resource and a professional reference. The hardbound format ensures durability, making it suitable for long-term use in institutions, libraries, and industry settings.
Whether you are preparing for exams or working in the pharmaceutical industry, this book is an essential guide to mastering the drug approval process.
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