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Pharmaceuticals Nutraceuticals to A Shift in Disease Prevention Pharmaceuticals Nutraceuticals to A Shift in Disease Prevention Dilip Ghosh R. B. Smarta CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2017 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Printed on acid-free paper Version Date: 20160414 International Standard Book Number-13: 978-1-4822-6075-5 (Hardback) This book contains information obtained from authentic and highly regarded sources. Reasonable efforts have been made to publish reliable data and information, but the author and publisher cannot assume responsibility for the validity of all materials or the consequences of their use. The authors and publishers have attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to publish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmit- ted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www.copyright. com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Library of Congress Cataloging‑in‑Publication Data Names: Ghosh, Dilip K., author. | Smarta, R. B., 1944- author. Title: Pharmaceuticals to nutraceuticals : a shift in disease prevention / Dilip Ghosh and R. B. Smarta. Description: Boca Raton : Taylor & Francis/CRC Press, 2017. | Includes bibliographical references and index. Identifiers: LCCN 2016015578 | ISBN 9781482260755 (hardback : alk. paper) Subjects: | MESH: Dietary Supplements--standards | Functional Food--standards | Pharmaceutical Preparations | Holistic Health Classification: LCC RM301 | NLM QU 145.5 | DDC 615.1--dc23 LC record available at https://lccn.loc.gov/2016015578 Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com Contents Authors ......................................................................................................................ix Contributor ................................................................................................................xi Introduction ............................................................................................................xiii Section i introduction Chapter 1 Redefining Nutraceutical and Functioning Foods as Part of a Journey from Pharma to Nutra .............................................................3 R. B. Smarta Chapter 2 Holistic Health through Nutrition, Diet, and Nutraceuticals for Prevention and Treatment ...................................................................17 R. B. Smarta Chapter 3 A Paradigm Shift from Cure to Prevention and Treatment ...............25 R. B. Smarta Chapter 4 Traditional and Modern Medicine: Filling the Gap ...........................35 Dilip Ghosh Section ii Quality–Safety–efficacy: three Mantras Chapter 5 Drug–Nutrient Interactions: Their Role in Clinical Outcomes ..........51 Dilip Ghosh Chapter 6 Existing and Innovative Models of Health and Disease: Elaborating on Foods versus Drugs ...................................................61 R. B. Smarta v vi Contents Section iii Marketing and Product Positioning Chapter 7 Market Dynamics and Evolution in Nutraceuticals ...........................73 R. B. Smarta Chapter 8 Business Perspective ..........................................................................87 R. B. Smarta Chapter 9 Science to Business Viability .............................................................97 R. B. Smarta Section iV Regulatory Perspective Chapter 10 The Role of Nanoparticles in Both Nutraceutical and Pharmaceutical Products ..................................................................109 Dilip Ghosh Chapter 11 A Regulatory Perspective of Nutraceuticals and Phytomedicines in India ...................................................................121 R. B. Smarta Section V Underpinning Science Chapter 12 Vitamin E in Health and Wellness: What Would Be the Ideal Therapeutic Dosage? ........................................................................133 Dilip Ghosh and Rohit Ghosh Chapter 13 Clinical Applications of Metabolites and Metabolomics .................161 Dilip Ghosh Contents vii Section Vi new Journeys through categorization Chapter 14 Medical Foods: A New Domain in the Food–Drug Interphase .......173 Dilip Ghosh Chapter 15 Probiotics: From Bench to Market ...................................................183 Dilip Ghosh Chapter 16 The Combination of Foods and Drugs: Advantages and Drawbacks ........................................................................................193 R. B. Smarta Section Vii Future trends Chapter 17 The Role of Food Bioactives in Disease Prevention ........................205 R. B. Smarta Chapter 18 The Journey from Personalized Medicine to Personalized Nutrition ...........................................................................................223 Dilip Ghosh Chapter 19 Quality Controversies in Phytopharmaceuticals ..............................247 Dilip Ghosh Index ......................................................................................................................259 Authors Dilip Ghosh, PhD, is an international speaker, facilitator, and author. He is pro- fessionally associated with Soho Flordis International (SFI) and Western Sydney University, and is an Honorary Ambassador with the Global Harmonization Initiative (GHI), all in Australia. With more than 20 years of experience in both the pharmaceutical and food and nutrition industries, he is one of the pioneer researchers to assess the health claim opportunities of potential functional food ingredients and complementary medicines through an evaluation of the current scientific evidence–based and related claims, providing commentaries on the gaps in science, including potential requirements for research, such as human studies. Dr. Ghosh received a PhD in biomedical science from the University of Calcutta, India, along with a BSc (Hons) and MSc in zoology/microbiology and an MPhil in environmental sciences. Dr. Ghosh has published more than 60 papers in peer-reviewed journals and numerous articles in food and nutrition magazines and books. His recent books, Biotechnology in Functional Foods and Nutraceuticals, Innovation of Healthy and Functional Foods, and Clinical Aspects of Functional Foods and Nutraceuticals, were all published by CRC Press/Taylor & Francis in 2010, 2012, and 2014, respec- tively. He is the review editor of Frontiers in Nutrigenomics (2011–present), the American Journal of Advanced Food Science and Technology (2012–present), the Journal of Obesity and Metabolic Research (2013–present), and the Journal of Bioethics (2013–present). He was an associate editor and member of Toxicology Mechanisms and Methods, Taylor & Francis (2006–2007), and is a columnist for the World of Nutraceuticals. Dr. Ghosh is also in executive member and advisor of the Health Foods and Dietary Supplements Association (HADSA). R. B. Smarta, PhD, has designed management agendas for profitable growth and relevant expansion, launching new concepts, ideas, and projects for national and global clients in pharmaceuticals, nutraceuticals, and wellness. Dr. Smarta has been in the industry for more than four decades and in consulting for a little more than three decades. He is the founder and managing director of Interlink Marketing Consultancy Pvt. Ltd. In addition to a postgraduate degree in organic chemistry, Dr. Smarta earned an MMS in marketing from the University of Mumbai. He holds a doctorate (PhD) in management from the University of East Georgia, is a Fellow of the Royal Society of Arts and Commerce (FRSA), and is a Certified Management Consultant (CMC). He has added value and created an impact on the performance of a wide variety of clients at national and multinational corporations. As an advocate of this nascent and essential industry of nutrition and nutraceuti- cals, Dr. Smarta is assisting in shaping the industry and its agenda with the help of industry leaders, members, and regulatory bodies through India’s Health Foods and Dietary Supplements Association as an Honorary Secretary. ix x Authors Dr. Smarta has penned eight books in the areas of pharma marketing and pharma- ceutical business and nutraceuticals. Some of his titles have also been translated into German. He regularly contributes articles to several dailies and industry periodicals. He has produced video-based training packages called Interact for corporate train- ers to enhance their skills on an ongoing basis. Dr. Smarta is a recipient of many national awards.

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