{"product_id":"a-textbook-of-pharmaceutical-regulatory-science","title":"A Textbook of Pharmaceutical Regulatory Science","description":"\u003cp data-start=\"0\" data-end=\"387\"\u003e“Pharmaceutical Regulatory Science” is a comprehensive and student-friendly book that provides a clear understanding of regulatory principles governing the development, approval, and marketing of pharmaceutical products. The book presents the subject in a simple and systematic manner, enabling readers to grasp both theoretical concepts and practical applications in regulatory affairs.\u003c\/p\u003e\n\u003cp data-start=\"389\" data-end=\"820\"\u003eThe text covers the complete process of drug discovery and development, including preclinical and clinical studies, along with detailed insights into regulatory approval pathways such as Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA). It also explains the differences between innovator and generic products, highlighting their regulatory requirements and approval processes.\u003c\/p\u003e\n\u003cp data-start=\"822\" data-end=\"1156\"\u003eIn addition, the book discusses regulatory frameworks and authorities across various countries, providing a global perspective on pharmaceutical regulations. It includes important topics such as drug master files, Common Technical Document (CTD) and eCTD formats, and procedures for registration and export of pharmaceutical products.\u003c\/p\u003e\n\u003cp data-start=\"1158\" data-end=\"1528\"\u003eThe book further explores clinical trials, Good Clinical Practices (GCP), pharmacovigilance, and quality management systems, emphasizing the importance of safety, efficacy, and compliance throughout the product lifecycle. Key regulatory concepts, documentation practices, and guidelines are also presented to strengthen understanding of real-world regulatory operations.\u003c\/p\u003e\n\u003cp data-start=\"1530\" data-end=\"1840\" data-is-last-node=\"\" data-is-only-node=\"\"\u003eWith its structured approach and focus on practical relevance, this book serves as a valuable resource for developing knowledge and skills in pharmaceutical regulatory science, supporting learners in understanding global regulatory requirements and professional responsibilities in the pharmaceutical industry.\u003c\/p\u003e","brand":"Prime Publishing House","offers":[{"title":"Default Title","offer_id":52726616621375,"sku":null,"price":140.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0977\/4071\/8399\/files\/20_PharmacenuticalRegulatoryScience_DrCharushilaJBhangale_1.jpg?v=1776068775","url":"https:\/\/primebookss.in\/products\/a-textbook-of-pharmaceutical-regulatory-science","provider":"Prime Publishing House","version":"1.0","type":"link"}