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Preface

T he book Industrial Pharmacy II is designed specifically as per PCI (Pharmacy

Council of India) B Pharmacy Seventh Semester students. The book covers the

entire syllabus prescribed by PCI Course Regulation, 2014 in a very simple and precise

manner to meet the demanding needs of the pharmacy aspirants. This book covers

wide areas and contains a comprehensive description of current existing knowledge

of drug regulatory affairs. The text not only deals with the basic concepts but also

emphasizes technical and practical aspects of the subject. The book is primarily intended

as a textbook for students of pharmacy for degree and masters courses in drug

regulatory affairs. The book is also of great help for technocrats who want to pursue

career in regulatory affairs department in pharmaceutical industry. Being an

interdisciplinary subject, it is today covering a wide range of interest among the

students, teaching and industry people. Taking this increasing interest into account,

this book gives a comprehensive introduction to the subject.

The book contains numerous specimens, vivid illustrations, tables, diagrams and

flow diagrams to present the ideas. The distinguishing feature is a summary of all the

units at the end of each unit. The structure and the content of the book have changed

to reflect modern thinking and current university curricula throughout the world. In

spite of great care there might be some mistakes and deficiencies. We will be grateful

for giving suggestions to improve. So go through the content and do mail to me at

gbitsian@rediffmail.com.

Gaurav Agarwal

Jyoti Ghangas

I

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