A Concise Textbook of Drug Regulatory Affairs
₹290.00
This book has 12 chapters covering nearly all the areas of Drug Regulatory Affairs. Various aspects of Drug Regulatory Affairs such as new drug approval procedure, pharmacovigilance, product recall, evolution of drug regulations in the United States of America (USA) and process of drug approval in the USA and European Union, bioequivalence regulations, electronic Common Technical Documents (eCTD), environmental regulations, orphan drugs pharmaceutical pricing and control policy, Pharmacovigilance system in India and the USA, Product Recall, regulations of pharmaceutical drug promotion and Pharmacy Practice regulations are covered in this book. As a whole, the book is a comprehensive reference book on regulatory affairs and will be very useful for the practicing professionals and students alike.
Categories: | Academic/Reference, Textbook/Manual |
---|
Editor | |
---|---|
Format |
Related products
-
Internationalization of Higher Education: The Dynamics of Educational Ecology
Mobilities of scholars seeking knowledge has been a part of the university ideal for centuries. History holds testimony to the fact that these mobilities have also altered the lives of people in different regions. Universities have played pivotal role in the movement of people across borders and the resultant transformation of societies due to transcultural interactions. In this book, the editors have brought together ideas on the changing dynamics of these mobilities of scholars and interconnectedness of higher education institutions in today’s world. Attempt is also made to record the implications of these international collaborations in knowledge generation and dissemination of the educational ecology.
-
Vaidehi Kathana
Vaidehi Kathana is the first full-length literary critical study of the fictional, non fictional and poetic narratives of Vaidehi, who is considered to be one of the most celebrated contemporary Indian writers in Kannada. This work reviews, introduces, discusses and interprets all the writings of Vaidehi, which include short stories, poems, essays and a novel. The book examines how this great Indian writer has been reacting and responding to her time and space for the last four decades. The book shows how Vaidehi?s poetics has so subtly blended with her politics thereby creating some of the outstanding masterpieces in poetry and fiction of our times. The book discusses the special features of Vaidehi?s feminist perspectives as well as the uniqueness of her narrative skills. Arguing that Vaidehi?s spiritual triumph is demonstrated in her technical triumph, the book draws the attention of the non-Kannada readers to the entire body of Vaidehi?s writings. Lucidly translated into English by the noted translator O L Nagabhushana Swamy, T P Ashoka?s Vaidehi Kathana provides a meaningful opportunity for the non-Kannada readers to familiarize themselves with one of the greatest contemporary writers of India. T P Ashoka?s Vaidehi Kathana is a significant contribution to modern Indian literary criticism. The book provides an interesting reading not only to the students of literature, researchers and teachers but also appeals to the general readers.
-
Mysore History(Christa Shaka 1800 Ra Modalina Mysooru ithihaasa)
Author: D S Achuta Rao Translator: S Narendra Prasad
೧೮೦೦ ಕ್ರಿ. ಶ. ದ ಹಿಂದಿನ ಮೈಸೂರು ಇತಿಹಾಸವು ಪ್ರೊ. ಡಿ ಎಸ್ ಅಚ್ಯುತ ರಾವ್ ಅವರ ಜೀವನ ಮತ್ತು ಕೆಲಸದ ಬಗ್ಗೆ. ಮೈಸೂರು ಇತಿಹಾಸದ ಕುರಿತಾದ ಅವರ ಸಂಶೋಧನೆಯು 1940-65ರ ಅವಧಿಯಲ್ಲಿ ಅವರು ಪ್ರಕಟಿಸಿದ ಹತ್ತು ಸೂಚ್ಯಂಕ ಲೇಖನಗಳಿಂದ ಪ್ರತಿನಿಧಿಸುತ್ತದೆ. ಅವರು ಭಾರತದ ಇತಿಹಾಸ ಮತ್ತು ಅದರ ಅದ್ಭುತ ಭೂತಕಾಲವನ್ನು ಸಕ್ರಿಯವಾಗಿ ಜನಪ್ರಿಯಗೊಳಿಸಿದರು. ಮಹಾರಾಜಾಸ್ ಕಾಲೇಜ್ ಹಿಸ್ಟರಿ ಸೊಸೈಟಿ, ಭಾರತದ ವಸಾಹತು ಸಂಶೋಧಕರು ಮತ್ತು ಕನ್ನಡ ವಿಶ್ವಕೋಶದಲ್ಲಿ ಮೈಸೂರು ಸರ್ಕಾರದ ಉಪಕ್ರಮದಿಂದ ಭಾರತೀಯ ಇತಿಹಾಸದಲ್ಲಿ ಉಪಕ್ರಮಗಳನ್ನು ಪ್ರಸ್ತುತಪಡಿಸುವುದರಿಂದ ಅಂತಹ ಮೂರು ಲೇಖನಗಳನ್ನು ಸೇರಿಸಲಾಗಿದೆ. ಎರಡನೇ ಭಾಗದಲ್ಲಿ ಅವರ ಜೀವನಚರಿತ್ರೆಯಲ್ಲಿ, ಅವರ ವಿದ್ಯಾರ್ಥಿಗಳು ಮತ್ತು ಮಕ್ಕಳು ಶಿಕ್ಷಕ ಮತ್ತು ತಂದೆಯಾಗಿ ಅವರ ಜೀವನದ ಬಗ್ಗೆ ಬರೆದಿದ್ದಾರೆ, ಅವರ ಅವಧಿಯ ಸಂದರ್ಭವನ್ನು ಒದಗಿಸಿದ್ದಾರೆ. ಪುಸ್ತಕವು ಕಳೆದ ಶತಮಾನದ ಮಧ್ಯದಲ್ಲಿ ಇತಿಹಾಸ ಸಂಶೋಧನೆಗೆ ಆಸಕ್ತಿದಾಯಕ ವಿಂಡೋವನ್ನು ಪ್ರಸ್ತುತಪಡಿಸುತ್ತದೆ.
Interested readers may write to us at mup@manipal.edu about purchasing the book.
-
Kannada Theatre History 1850-1950: A Sourcebook
This source book on Kannada theatre history is a valuable contribution to the larger field of Indian Theatre Studies. Avoiding the shortcuts of an overview or a Wikipedia-like assemblage of information, it delves into the lives, histories, struggles, debates and anecdotes surrounding some of the most pioneering figures in the shaping of Kannada theatre between 1850-1950. The selection of primary sources, most of which are being made available in English for the first time, is nothing short of a revelation in the way it illuminates insights into the actual making and thinking of theatre practice. Here we have a model of how the construct of ?Indian Theatre? can be textured, inflected, individuated and problematized at regional, local and intracultural levels. ? Rustom Bharucha .This book is a labour of love by scholars who not only love Kannada theatre, but want to pass on their enjoyment of it. Delving deep into folklore oral history, local history, gossip debate and discourse, the editors bring out the world of Kannada theatres in pluralistic terms. Scholarship and playfulness combine to create a powerful act of storytelling where the book itself mimics the career of Kannada theatre. As an anthology it becomes an initiation rite, an introduction to all the great figures, not as hagiography but as nuanced analysis. Big questions and little questions combine to create both a sense of combativeness and a wonderful feeling of homecoming. Like tricksters, they break the binaries of tradition and modernity, treating it almost like a bad play which needs new scripts and new performers. A wonderful anthology. A deeply desi book, with all the cosmopolitanism of world theatre. ? Shiv Visvanathan
-
Ayurvedic Inheritance- A Reader’s Companion
In ancient India, learning spanned four quarters of one’s life. Learning was sought from the teacher, from one’s individual effort, from fellow students and in the last quarter, from the school of life itself. This book belongs to the third quarter for students of Ayurveda regardless of their background in medicine, science, or humanities. Apart from topics in the eight branches of Ayurveda, the book also deals with Ayurvedic Biology which seeks to study the concepts and procedures of Ayurveda with the tools of modern biology. M S Valiathan is a National Research Professor of the Government of India. He is a medical graduate from the University of Kerala and completed his postgraduate training in general surgery from the University of Liverpool and other hospitals in the UK. He did his specialisation in cardiac surgery from the Johns Hopkins and Georgetown University Hospitals in the US. He was a cardiac surgeon for over three decades. His shift to Ayurvedic studies resulted in the publication of three volumes on Caraka, Susruta and Vagbhata, and an Introduction to Ayurveda. The Department of Science and Technology set up a Task Force in Ayurvedic Biology under his chairmanship to promote research in the nascent discipline.
Interested readers may write to us at mup@manipal.edu about purchasing the book.
International Edition available on South Asia Edition available on
-
Manipal Manual of Ear Mould Making
Manipal Manual of Ear Mould Making is a comprehensive workbook of value to students of Audiology & hearing professionals who wish to understand the nuances of this skill that is paramount for optimization of hearing aid fitting. This is a compilation of the authors? years of experience in the deft skills of ear mould making and patient care in Manipal Ear Mould lab. Considerable efforts have gone in to bringing out this manual by incorporating appropriate pictures, stepwise procedures and simple instructions. This manual, besides appraising the readers of the procedure would also assist them in learning the dos and donts picked up out of the authors? clinical experience. This will be a reflection of our ongoing efforts to derive the best out of the rapidly developing technology in the area of hearing impairment.
-
Kriti Jagattu
ಪ್ರೊ. ಟಿ. ಪಿ. ಅಶೋಕ ಅವರ ಇತ್ತೀಚಿನ ಕೃತಿ ಕೃತಿ ಜಗತ್ತು ಇಪ್ಪತ್ತಾರು ಪ್ರಬಂಧಗಳನ್ನು ಒಳಗೊಂಡ ಪುಸ್ತಕವಾಗಿದ್ದು, ವಿವಿಧ ದೇಶಗಳು, ಭಾಷೆಗಳು, ಸಂಪ್ರದಾಯಗಳು, ಪ್ರಕಾರಗಳು ಇತ್ಯಾದಿಗಳಿಗೆ ಸಂಬಂಧಿಸಿದ ಕೃತಿಗಳನ್ನು ಪರಿಚಯಿಸುವ, ವಿಶ್ಲೇಷಿಸುವ, ವಿಮರ್ಶಿಸುವ ಮತ್ತು ಸ್ಪಷ್ಟಪಡಿಸುವ ಮತ್ತು ಸಾಹಿತ್ಯದ ಒಂದು ನೋಟವನ್ನು ನೀಡುತ್ತದೆ. ಇಡೀ ಪ್ರಪಂಚ. ಪ್ರಬಂಧಗಳು ಸಾಮಾಜಿಕ, ಸಾಂಸ್ಕೃತಿಕ ಮತ್ತು ರಾಜಕೀಯ ಘಟನೆಗಳಿಗೆ ಮತ್ತು ಕಳೆದ ಐನೂರು ವರ್ಷಗಳಲ್ಲಿ ನೈತಿಕ, ಮಾನಸಿಕ ಮತ್ತು ಆಧ್ಯಾತ್ಮಿಕ ಬಿಕ್ಕಟ್ಟುಗಳಿಗೆ ಪ್ರಪಂಚದಾದ್ಯಂತದ ಶ್ರೇಷ್ಠ ಬರಹಗಾರರ ಪ್ರತಿಕ್ರಿಯೆಯನ್ನು ಪರಿಣಾಮಕಾರಿಯಾಗಿ ಪ್ರಸ್ತುತಪಡಿಸುತ್ತವೆ. ಈ ಕೃತಿ ಪ್ರಪಂಚವು ಕನ್ನಡ ಸಾಹಿತ್ಯ ಪ್ರಪಂಚದೊಂದಿಗೆ ಸಂಬಂಧವನ್ನು ಸ್ಥಾಪಿಸುತ್ತದೆ ಮತ್ತು ಆದ್ದರಿಂದ ಪುಸ್ತಕದ ವಿಶೇಷ ಮಹತ್ವವನ್ನು ಹೊಂದಿದೆ.
-
Comets – Nomads of the Solar System
This book introduces the general reader to the world of comets – those celestial visitors from the outer Solar System that occasionally visit the Earth’s neighbourhood and put up spectacular shows in the night sky. The world had geared up for just such a show at the end of 2013, when Comet ISON was expected to light up the night sky. Using the occasion to bring the world of comets to those interested, this book is a delightful read about the quirky world of these unpredictable visitors. Apart from lucidly and accurately updating the reader about what comets are, where they come from, why is it that they assume the fantastic shapes they do etc. “Comets” also regales the reader with myths about comets in various cultural contexts, snippets about famous comets in the history of mankind, anecdotes on comet discoveries and discoverers, the bewildering procedures followed while naming comets and much more. The book takes a hard look at the hype surrounding the fiery expectations about Comet ISON an cautions the reader that, while there was a good chance of the comet blazing forth in the skies of December 2013, there was a realistic chance that the comet would not survive its close encounter with the Sun. Sadly, the pessimistic predictions came true and the comet disintegrated as it went around the Sun. As we wait for chance to throw us a Great Comet to gaze at in the future, “Comets: Nomads of the Solar System” is an excellent guide to prepare for the event!
Interested customers may write to us at mup@manipal.edu about purchasing the book.
Also available on