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About The Book
Description
Author
The purpose of this book is to introduce Pharmacy students to fundamentals of principles practices and technologies involved in product development and also about Regulatory affairs.An excellent presentation is used in this book to demonstrate the interrelationship between laboratory scaling of pharmaceutical products pilot plants and regulatory affairs. An extensive overview of various regulatory bodies their guidelines and regulations governing the manufacturing and compounding of Pharmaceuticals are also explained.The present text book is made completely as per PCI syllabus to make an easy understanding for the students. Each chapter of this book is written at a level of students requirements. The objective upon completion of subject student can be able to 1. Know the process of Technology transfer from lab scale to commercial scale. 2. Know the process of pilot plant scale up of Pharmaceutical dosage form. 3. Know the various regulatory guidelines for pharmaceutical Industry. 4.Understand the approval process and regulatory requirements for drug product.