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
-
The Practice of Geopolitics
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 alternativeWeltanschauung 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.
-
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.
-
Pharmaceutical Consumer Complaints: A Guide to Academia and Pharmaceutical Industry
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.
-
The Path of Proofs: Pramanapaddhati of Sri Jayatirtha
The Path of Proofs: Pramanapaddhati of Sri Jayatirtha Epistemology of the Dvaita school of thought is presented in this short monograph Pramanapaddhati the Path of Proofs, authored by Sri Jayatirtha. Epistemology is the science of knowledge that deals with the origin and nature of cognitive events and their means. Acarya Madhva, the proponent of the Dvaita school, has explained about the epistemology of this new school in his works. Since Madhva’s language is profound and the elucidations are scattered over his several works, it is difficult to comprehend for a novice. Hence, Pramanapaddhati was composed by his successor of third generation Sri Jayatirtha. The simple and captivating style of this work is sure to ignite the interest in the readers to conduct further study in detail. This work is not only regarded as a standard textbook of Dvaita studies, but also considered as a basic authentic work in the Dvaita dialectic literature. The work is classified into three chapters; Pratyaksa, Anumana and Agama as a compendious yet full treatment of the Dvaita epistemology in smaller captions. Its discussion on the standpoints of other schools on various topics and their criticism is not much detailed. However, it is systematized and presented in an easily comprehendible style that can make even a novice understand the intricacies of Dvaita epistemology. The unique commentary skill of Sri Jayatirtha comprises of profound scholarship, style of exposition, lucid language, commitment to the original author, views on opposition with thorough knowledge, logical integrity, appropriate and comprehensive method of thinking. This work is rendered into English by Prof Shrinivasa Varakhedi adopting the mirror-translation method.
-
Educational Philosophy of Dr S Radhakrishnan
Educational Philosophy of Dr S Radhakrishnan effectively presents Radhakrishnan?s thoughts, highlighting their relevance to the present day. The author has at length discussed Indian Philosophy in comparison with the Western thought and successfully established that the East-West synthesis as propagated by Radhakrishnan is the need of the hour. The readers will also get an account of Radhakrishnan?s life story in the backdrop of the political history of pre and post-Independent India. This book is Dr V N Deshpande?s posthumous publication.
-
Parkinson’s Disease in India: From Clinic to Bench
The book fills a void in the knowledge about difference in Parkinson’s disease as seen India, if any from the rest of the world. It will provide a reference for any student of neurology wanting to learn the finer nuances of Parkinson’s disease in India. The book is written by Indian authors who have studied different aspects of Parkinson?s disease in depth, covering all aspects of Parkinson’s disease. The book is painstakingly drafted to cover all aspects of Parkinson’s disease from demography, etiology, clinical features (both motor and non-motor), complications, treatment modalities, its impact on the sufferer and the family and the financial aspect.
-
Performing Self/Performing Gender: Reading the lives of Women Performers in Colonial India
This book explores the shifting identity of the female performer in India, starting from the late 19th century to the early years of independence, through the study of autobiographies and memoirs. It attempts to make visible the actress figure by entering the history of performance, guided by the voice of the female performer. The discussion on performing woman in this book spans across the performing traditions of the tawaif, actresses in public theatre, early Indian film actresses, and actresses in the Indian People?s Theatre and the Prithvi Theatre. Sheetala Bhat is an actress and a writer from Sirsi, a small town in the Western Ghats of Karnataka. She holds an MA in English Literature from Manipal Centre for Philosophy and Humanities, Manipal University, Manipal. She worked with Chintana repertory, exploring the possibilities of theatre in education in government schools in Karnataka. She writes short stories and poetry in Kannada. Being a reclusive reader and an enthusiastic actress, she often finds herself rummaging and weaving in between the fields of theatre and Indian literature, with an emphasis on the gender concerns in these areas. Performing Self, Performing Gender: Reading the Lives of Women Performers in Colonial India is her first book.
-
Writing the self in Illness: Reading the Experiential through the Medical Memoir
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.