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.
Interested readers may write to us at mup@manipal.edu about purchasing the book.
Categories: | Academic and Reference, Textbook/Manual |
---|
Editor | |
---|---|
Format |
Related products
-
Childhood Cancer
Childhood Cancer is a major medical problem in most of the societies of the modern world. Though enough literature is available on the subject, it is not easily intelligible to common people. An ordinary parent whose ward is affected by any form of childhood cancer would beat a loss without the basic information. This book is aimed at educating a non-professional who wishes to grasp the problem in detail and in a simple way. The book primarily deals with the signs and symptoms of cancer in children which enable early detection. It is written in a lucid manner to remove the myth among parents that diagnosis of cancer in children amounts to a death sentence. Many of the childhood cancers, if detected early, can be cured completely, and the patients can live the rest of their lives like any other normal people. The book is an attempt to create this awareness among parents through proper information about the disease. Further, the book would also serve as a manual for MBBS students and professionals in other fields for primary treatment and management of the childhood cancer patients.
Interested customers may write to us at mup@manipal.edu about purchasing the book.
Also available on
-
Kathana Bharathi
Author: T P Ashoka
ಕಥನ ಭಾರತಿಯು ವಿವಿಧ ಭಾರತೀಯ ಭಾಷೆಗಳಾದ ಕನ್ನಡ, ಹಿಂದಿ, ಬೆಂಗಾಲಿ, ಗುಜರಾತಿ, ಮಲಯಾಳಂ, ಮರಾಠಿ, ಒರಿಯಾ, ಪಂಜಾಬಿ ಮತ್ತು ಉರ್ದುಗಳಲ್ಲಿ ಬರೆಯಲಾದ ಆಧುನಿಕ ಶ್ರೇಷ್ಠ ಸಾಹಿತ್ಯದ ಇಪ್ಪತ್ತು ಸಾಹಿತ್ಯ ವಿಮರ್ಶಾತ್ಮಕ ಪ್ರಬಂಧಗಳ ಸಂಗ್ರಹವಾಗಿದೆ. ಪುಸ್ತಕದಲ್ಲಿ ಚರ್ಚಿಸಲಾದ ಭಾರತೀಯ ಲೇಖಕರಲ್ಲಿ ಜನಪ್ರಿಯ ಲೇಖಕರಾದ ಅಲೋಕ್ ಭಲ್ಲಾ, ಅಮೃತಾ ಪ್ರೀತಮ್, ಬೇಗಂ ರೋಕ್ವಿಯಾ ಸಖಾವತ್ ಹುಸೇನ್, ಭೀಮರಾವ್ ರಾಮ್ಜಿ ಅಂಬೇಡ್ಕರ್, ಭೀಶಮ್ ಸಾಹ್ನಿ, ಚಂದ್ರಶೇಖರ ಕಂಬಾರ, ಗಿರೀಶ್ ರಘುನಾಥ್ ಕಾರ್ನಾಡ್, ಗೋಪಿನಾಥ್ ಮೊಹಾಂತಿ, ಜಾನಕಿ ಶ್ರೀನಿವಾಸ ಮೂರ್ತಿ (ವೈದೇಹಿ, ಕೋತಾ ಸುನಿವಾಸ ಮೂರ್ತಿ) ಸೇರಿದ್ದಾರೆ. ಶಿವರಾಮ ಕಾರಂತ್, ಲಕ್ಷ್ಮಣ ಮಾನೆ, ಮಹಾಶ್ವೇತಾದೇವಿ, ಮಾಸ್ತಿ ವೆಂಕಟೇಶ ಅಯ್ಯಂಗಾರ್, ಮೋಹನ್ದಾಸ್ ಕರಮಚಂದ್ ಗಾಂಧಿ, ಮುನ್ಷಿ ಪ್ರೇಮಚಂದ್, ಪನ್ನಾಲಾಲ್ ನಾನಾಲಾಲ್ ಪಟೇಲ್, ರವೀಂದ್ರನಾಥ ಠಾಗೋರ್, ಸಾದತ್ ಹಸನ್ ಮಂಟೋ, ತಕಳಿ ಶಿವಶಂಕರ ಪಿಳ್ಳೈ, ಉಡುಪಿ ರಾಜಗೋಪಾಲಾಚಾರ್ಯ ಅನಂತಮೂರ್ತಿ ಮತ್ತು ಯಶಪಾಲ. ಇಪ್ಪತ್ತು ಸಾಹಿತ್ಯ ವಿಮರ್ಶಾತ್ಮಕ ಪ್ರಬಂಧಗಳು ತಮ್ಮ ಆಯ್ದ ಬರಹಗಳನ್ನು ಪರಿಶೀಲಿಸುತ್ತವೆ, ಪರಿಚಯಿಸುತ್ತವೆ, ಚರ್ಚಿಸುತ್ತವೆ ಮತ್ತು ವ್ಯಾಖ್ಯಾನಿಸುತ್ತವೆ. ಕಳೆದ ನೂರೈವತ್ತು ವರ್ಷಗಳಲ್ಲಿ ಭಾರತೀಯ ಶ್ರೇಷ್ಠ ಲೇಖಕರು ತಮ್ಮ ಸಮಯ ಮತ್ತು ಜಾಗಕ್ಕೆ ಹೇಗೆ ಪ್ರತಿಕ್ರಿಯಿಸಿದ್ದಾರೆ ಮತ್ತು ಪ್ರತಿಕ್ರಿಯಿಸಿದ್ದಾರೆ ಎಂಬುದನ್ನು ಈ ಲೇಖನಗಳು ಪರಿಶೀಲಿಸುತ್ತವೆ. ವಸಾಹತುಶಾಹಿ ಅನುಭವ, ವಿಭಜನೆಯ ಆಘಾತ ಮತ್ತು ಸ್ವಾತಂತ್ರ್ಯಾನಂತರದ ಸಾಮಾಜಿಕ ರಾಜಕೀಯ ಬೆಳವಣಿಗೆಗಳು ಈ ಬರಹಗಾರರ ಬರಹಗಳಲ್ಲಿ ಪ್ರಬಲ ನಿರೂಪಣೆಗಳು ಮತ್ತು ರೂಪಕಗಳ ರೂಪದಲ್ಲಿ ಅಭಿವ್ಯಕ್ತಿಯನ್ನು ಕಂಡುಕೊಂಡಿವೆ. ಟಿ ಪಿ ಅಶೋಕ ಅವರ ಕಥನ ಭಾರತಿ ಈ ಬರಹಗಳ ವಿಮರ್ಶೆ. ಆಧುನಿಕ ಭಾರತೀಯ ಸಾಹಿತ್ಯದಲ್ಲಿನ ಈ ಅಧ್ಯಯನಗಳು ಆಧುನಿಕ ಭಾರತೀಯ ಸಾಹಿತ್ಯ ವಿಮರ್ಶೆಗೆ ಅಮೂಲ್ಯ ಕೊಡುಗೆಯಾಗಿದೆ. ಪುಸ್ತಕವು ಸಾಹಿತ್ಯದ ವಿದ್ಯಾರ್ಥಿಗಳು, ಸಂಶೋಧಕರು ಮತ್ತು ಶಿಕ್ಷಕರಿಗೆ ಆಸಕ್ತಿದಾಯಕ ಓದುವಿಕೆಯನ್ನು ಒದಗಿಸುತ್ತದೆ ಆದರೆ ಸಾಮಾನ್ಯ ಓದುಗರನ್ನೂ ಆಕರ್ಷಿಸುತ್ತದೆ.
Interested readers may write to us at mup@manipal.edu about purchasing the book. -
Ayurvedic Inheritance- A Reader’s Companion
Author: M S Valiathan
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
-
Pharmaceutical Consumer Complaints: A Guide to Academia and Pharmaceutical Industry
Editors: Girish Pai Kulyadi, Muddukrishna B S, Richa Ajay Dayaramani
This book is an excellent guide in analyzing consumer complaints and will aid the students who are yet to gain industry experience. It is necessary for resolving consumer complaints in pharmaceutical industry where such concerns are frequently received. The case studies provide a vivid description of defects that will help identify the nature of the issue, possible root cause of such complaints, and subsequent remediation.
Interested readers may write to us at mup@manipal.edu about purchasing the book.
-
The Practice of Geopolitics
Author: M D Nalapat
Intended to be a Practioner’s Guide to Geopolitics, the book provides a look into the thought processes that generate correct and timely analysis of global events. Geopolitics needs to weave within its analytical grasp economics, society, strategy and even culture, as the science deals with overall national capabilities as well as the mutal synergy and frictions between nations. Although a broad range of subjects has been covered in the book, each is anchored in the ground reality of events having a profound impact on the lives of citizens and on world events. The growing interconnectedness of the globe has resulted in a need to do away with the popular west centric models of international relations and to view events not through that single prism but from a holistic viewpoint that accepts the relevance and maturity of different histories and geographies. What the book provides is an alternative Weltanschauung to the dominant models of geopolitical analysis, so that the science is enabled to cross beyond the narrow boundaries which have confined. The scope and applicability of its analysis. The rise of Asia needs a geopolitical vision unique to the continent, and this is what has been provided by Professor Nalapat.
Interested readers may write to us at mup@manipal.edu about purchasing the book.
-
Writing the self in Illness: Reading the Experiential through the Medical Memoir
Author: Amala Poli
Writing the Self in Illness: Reading the Experiential Through the Medical Memoir is MUP’s refreshing venture into the developing fields of Medical and Health Humanities with an aim to consider the necessity of the narrative knowledge as complementary to the contemporary notions of well-being, illness, and healthcare.
Is individual happiness contingent on health and well-being “How does one find happiness in the throes of illness” In the present-day scenario, wherein medical practice is largely dominated by evidence-based understanding, diagnostic language, and problem-solving methods, the discipline of Medical Humanities emerges with a reciprocal dialogue between Humanities, Social Sciences, Health, and Medicine. The study of varied experiential narratives – literary works and unmediated accounts of patients and healthcare professionals, is foregrounded in Medical Humanities to amplify knowledge and understanding about the complexity of encounters with illness and their transformational quality in a nuanced manner. Both thought-provoking and informative, this publication brings about the anecdotal form of personal narratives in the light of medical discourses along with the specific cultural context of the narrative.
The present publication seeks to be an important reading for students and academics in the field of medical humanities, health professionals or medical practitioners, as well as scholars aspiring to venture into this flourishing field.Interested readers may write to us at mup@manipal.edu about purchasing the book.
-
Transformation Beyond Sight
Author: Jibu Thomas
Transformation Beyond Sight is a gripping narrative of the author’s experience in the hospital administration of Kasturba Hospital (KH), Manipal. As an experiential account, the present book provides insights into the thoughts, concerns, and apprehensions of prospective hospital administrators, and spotlights the vital role played by a hospital administrator in the day-to-day operations of KH, which is also an advanced healthcare facility.This book draws attention to the transformational quality of the author’s experiences to emphasize that the evolution in leadership and management of the teaching hospital went hand-in-hand with the transformation of the author’s administrative skills, and his own persona as a diligent administrator. The biographical undertone also provides an insight into the complex and dynamic healthcare environment, alongside the competencies, creativity, and mindfulness necessary for an administrator. This book narrates a hospital administrator’s engagements with the traditional processes and his attempts to bring about effective changes in the management and monitoring of operations of KH and the overall management of a healthcare facility.
Interested readers may write to us at mup@manipal.edu about purchasing the book.
-
Geoffrey Bawa – A Conscious Perception
This book is all about giving the readers a peek view into the life of Geoffrey Bawa; Sri Lanka’s most famous architect. an book that reveals an insight into his work through his most famous projects accompanied by beautiful hand-drawn illustrations. Alluring and simply authentic, these self-narrative illustrations are a result of personal experience. This book will give readers an understanding of how successfully Geoffrey Bawa had inculcated spaces, vistas, and landscape with that of the built environment bringing about a touch of Modern Tropism and fusing it together with the rich culture and traditions of Sri Lanka.
Interested readers may write to us at mup@manipal.edu about purchasing the book.