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{ "item_title" : "Comprehensive Guide to Pharmaceutical Regulatory Science", "item_author" : [" Dr K Nagasree", "Dr Konda Shravan Kumar", "Dr K N V Rao "], "item_description" : "Comprehensive Guide to Pharmaceutical Regulatory Science is an essential textbook designed to provide pharmaceutical professionals, students, and researchers with a deep understanding of regulatory science in the pharmaceutical industry. This book covers a wide range of topics including drug discovery, clinical trials, regulatory approval processes, and post-market surveillance. Key Features: In-depth Coverage: Learn about the complete regulatory landscape, including the stages of drug discovery and development, clinical trials, regulatory approval processes (NDA, IND, ANDA), and international guidelines (FDA, EMA, ICH).Authoritative Insights: Authored by renowned professionals with over 30 years of combined experience in pharmaceutical education, regulatory affairs, and pharmaceutical biotechnology.Global Perspective: Detailed insights into the regulatory frameworks of the US, EU, Japan, Canada, and India, with practical applications for professionals working in these regions.Real-World Applications: Understand the complexities of pharmaceutical regulation and how to navigate the approval process for drug products in various international markets.Perfect for Professionals & Students: This book is ideal for students pursuing B.Pharm, M.Pharm, PhD in pharmaceutical sciences, and for professionals seeking to deepen their knowledge of pharmaceutical regulatory practices.", "item_img_path" : "https://covers1.booksamillion.com/covers/bam/9/79/889/906/9798899064388_b.jpg", "price_data" : { "retail_price" : "23.90", "online_price" : "23.90", "our_price" : "23.90", "club_price" : "23.90", "savings_pct" : "0", "savings_amt" : "0.00", "club_savings_pct" : "0", "club_savings_amt" : "0.00", "discount_pct" : "10", "store_price" : "" } }
Comprehensive Guide to Pharmaceutical Regulatory Science|Dr K Nagasree

Comprehensive Guide to Pharmaceutical Regulatory Science

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Overview

Comprehensive Guide to Pharmaceutical Regulatory Science" is an essential textbook designed to provide pharmaceutical professionals, students, and researchers with a deep understanding of regulatory science in the pharmaceutical industry. This book covers a wide range of topics including drug discovery, clinical trials, regulatory approval processes, and post-market surveillance.

Key Features:

In-depth Coverage: Learn about the complete regulatory landscape, including the stages of drug discovery and development, clinical trials, regulatory approval processes (NDA, IND, ANDA), and international guidelines (FDA, EMA, ICH).

Authoritative Insights: Authored by renowned professionals with over 30 years of combined experience in pharmaceutical education, regulatory affairs, and pharmaceutical biotechnology.

Global Perspective: Detailed insights into the regulatory frameworks of the US, EU, Japan, Canada, and India, with practical applications for professionals working in these regions.

Real-World Applications: Understand the complexities of pharmaceutical regulation and how to navigate the approval process for drug products in various international markets.

Perfect for Professionals & Students: This book is ideal for students pursuing B.Pharm, M.Pharm, PhD in pharmaceutical sciences, and for professionals seeking to deepen their knowledge of pharmaceutical regulatory practices.

This item is Non-Returnable

Details

  • ISBN-13: 9798899064388
  • ISBN-10: 9798899064388
  • Publisher: Notion Press
  • Publish Date: April 2025
  • Dimensions: 9 x 6 x 0.86 inches
  • Shipping Weight: 1.13 pounds
  • Page Count: 386

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