This book is an extensive and student friendly textbook designed to cater to the present syllabus prescribed by the Pharmacy Council of India (PCI) for BPharm (Semester VII BP702T Industrial Pharmacy II, Semester VIII BP804ET Pharmaceutical Regulatory Science) and MPharm (Semester I MPH104T Regulatory Affairs). It is also a great resource for industry personnel and academicians involved in drug development and regulatory affairs.
From pilot plant scale-up and technology transfer to clinical trials, quality management systems and international registration processes, the book takes the reader from bench to bedside to the market, linking theory to practice in a regulatory context. Special focus is given to the regulatory contexts in India (CDSCO), the USA (FDA), the European Union
(EMA), Japan (PMDA), Australia (TGA) and Canada (Health Canada), so as to be globally aware. This book is a handy reference guide for undergraduate and postgraduate students, research students, and professionals in the pharmaceutical regulatory affairs field.
New to the second edition
Ø Every topic has been updated according to the new PCI syllabus of BPharm and MPharm courses.
Ø Recent updates to the regulations, new pharmaceutical guidelines and current practices from industry have been included to ensure the book is relevant.
Ø The sections on emerging topics, such as quality by design (QbD), industry 4.0 and 5.0, on digital GLP, the modern NDA review process, and on global harmonization have been expanded.
Ø New illustrations, tables, diagrams and flowcharts have been added to increase the ease of understanding complex concepts.
Ø All chapters have been restructured to be clearer and easier to read.
Ø Case studies, practical applications and industry focused discussions are included to bridge the theory and practice divide.
Ø Important definitions, highlighted key points, and quick-revision notes have been added to help with learning and retention.
Ø Practice questions at the end of the chapters can be used for examination practice and self-assessment.
Ø There is much more coverage of CDSCO regulations, ICH guidelines, clinical trials, technology transfer and global regulatory regimes.
.png)
.png)
