Topical Drug Bioavailability Bioequivalence And Penetration

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Topical Drug Bioavailability, Bioequivalence, and Penetration

Author : Vinod P. Shah
Publisher : Springer
ISBN 13 : 1493912895
Total Pages : 402 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis Topical Drug Bioavailability, Bioequivalence, and Penetration by : Vinod P. Shah

Download or read book Topical Drug Bioavailability, Bioequivalence, and Penetration written by Vinod P. Shah and published by Springer. This book was released on 2015-01-30 with total page 402 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative volume explores advances in the techniques used to measure percutaneous penetration of drugs and chemicals to assess bioavailability and bioequivalence and discusses how they have been used in clinical and scientific investigations. Seven comprehensive sections examine topics including in vitro drug release, topical drugs products, clinical studies, and guidelines and workshop reports, among others. The book also describes how targeted transdermal drug delivery and more sophisticated mathematical modelling can aid in understanding the bioavailability of transdermal drugs. The first edition of this book was an important reference guide for researchers working to define the effectiveness and safety of drugs and chemicals that penetrated the skin. This second edition contains cutting-edge advances in the field and is a key resource to those seeking to define the bioavailability and bioequivalence of percutaneously active compounds to improve scientific and clinical investigation and regulation.

Compounded Topical Pain Creams

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030967218X
Total Pages : 353 pages
Book Rating : 4.3/5 (96 download)

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Book Synopsis Compounded Topical Pain Creams by : National Academies of Sciences, Engineering, and Medicine

Download or read book Compounded Topical Pain Creams written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-07-21 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pain is both a symptom and a disease. It manifests in multiple forms and its treatment is complex. Physical, social, economic, and emotional consequences of pain can impair an individual's overall health, well-being, productivity, and relationships in myriad ways. The impact of pain at a population level is vast and, while estimates differ, the Centers for Disease Control and Prevention reported that 50 million U.S. adults are living in pain. In terms of pain's global impact, estimates suggest the problem affects approximately 1 in 5 adults across the world, with nearly 1 in 10 adults newly diagnosed with chronic pain each year. In recent years, the issues surrounding the complexity of pain management have contributed to increased demand for alternative strategies for treating pain. One such strategy is to expand use of topical pain medicationsâ€"medications applied to intact skin. This nonoral route of administration for pain medication has the potential benefit, in theory, of local activity and fewer systemic side effects. Compounding is an age-old pharmaceutical practice of combining, mixing, or adjusting ingredients to create a tailored medication to meet the needs of a patient. The aim of compounding, historically, has been to provide patients with access to therapeutic alternatives that are safe and effective, especially for people with clinical needs that cannot otherwise be met by commercially available FDA-approved drugs. Compounded Topical Pain Creams explores issues regarding the safety and effectiveness of the ingredients in these pain creams. This report analyzes the available scientific data relating to the ingredients used in compounded topical pain creams and offers recommendations regarding the treatment of patients.

Percutaneous Absorption

Author : Robert L. Bronaugh
Publisher : CRC Press
ISBN 13 : 9781420000948
Total Pages : 992 pages
Book Rating : 4.0/5 (9 download)

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Book Synopsis Percutaneous Absorption by : Robert L. Bronaugh

Download or read book Percutaneous Absorption written by Robert L. Bronaugh and published by CRC Press. This book was released on 1999-05-28 with total page 992 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since publication of the Second Edition in 1989, numerous innovations have occurred that affect the way scientists look at issues in the field of percutaneous absorption. Focusing on recent advances as well as updating and expanding the scope of topics covered in the previous edition, Percutaneous Absorption, Third Edition provides thorough coverage of the skin's role as an important portal of entry for chemicals into the body. Assembles the work of nearly 80 experts-30 more than the Second Edition-into a unified, comprehensive volume that contains the latest ideas and research! Complete with nearly 600 drawings, photographs, equations, and tables and more than 1600 bibliographic citations of pertinent literature, Percutaneous Absorption, Third Edition details the applied biology of percutaneous penetration factors that affect skin permeation, such as age, vehicles, metabolism, hydration of skin, and chemical structure in vivo and in vitro techniques for measuring absorption, examining factors influencing methodology such as animal models, volatility of test compound, multiple dosage, and artificial membranes procedures for use in transdermal delivery, exploring topics such as effects of penetration enhancers on absorption, optimizing absorption, and the topical delivery of drugs to muscle tissue And presents new chapters on mathematical models cutaneous metabolism prediction of percutaneous absorption in vitro absorption methodology dermal decontamination concentration of chemicals in skin transdermal drug delivery mechanisms of absorption safety evaluation of cosmetics absorption of drugs and cosmetic ingredients nail penetration Emphasizes human applications-particularly useful for pharmacists, pharmacologists, dermatologists, cosmetic scientists, biochemists, toxicologists, public health officials, manufacturers of cosmetic and toiletry products, and graduate students in these disciplines! An invaluable reference source for readers who need to keep up with the latest developments in the field, Percutaneous Absorption, Third Edition is also an excellent experimental guide for laboratory personnel.

Drug Delivery Approaches

Author : Bret Berner
Publisher : John Wiley & Sons
ISBN 13 : 1119772753
Total Pages : 466 pages
Book Rating : 4.1/5 (197 download)

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Book Synopsis Drug Delivery Approaches by : Bret Berner

Download or read book Drug Delivery Approaches written by Bret Berner and published by John Wiley & Sons. This book was released on 2021-08-04 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore this comprehensive discussion of the application of physiologically- and physicochemical-based models to guide drug delivery edited by leading experts in the field Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics delivers a thorough discussion of drug delivery options to achieve target profiles and approaches as defined by physical and pharmacokinetic models. The book offers an overview of drug absorption and physiological models, chapters on oral delivery routes with a focus on both PBPK and multiple dosage form options. It also provides an explanation of the pharmacokinetics of the formulation of drugs delivered by systemic transdermal routes. The distinguished editors have included practical and accessible resources that address the biological and delivery approaches to pulmonary and mucosal delivery of drugs. Emergency care settings are also described, with explorations of the relationship between parenteral infusion profiles and PK/PD. The future of drug delivery is addressed via discussions of virtual experiments to elucidate mechanisms and approaches to drug delivery and personalized medicine. Readers will also benefit from the inclusion of: A thorough introduction to the utility of mathematical models in drug development and delivery An exploration of the techniques and applications of physiologically based models to drug delivery Discussions of oral delivery and pharmacokinetic models and oral site-directed delivery A review of integrated transdermal delivery and pharmacokinetics in development An examination of virtual experiment methods for integrating pharmacokinetic, pharmacodynamic, and drug delivery mechanisms Alternative endpoints to pharmacokinetics for topical delivery Perfect for researchers, industrial scientists, graduate students, and postdoctoral students in the area of pharmaceutical science and engineering, Drug Delivery Approaches: Perspectives from Pharmacokinetics and Pharmacodynamics will also earn a place in the libraries of formulators, pharmacokineticists, and clinical pharmacologists.

Contact Dermatitis

Author : Peter J. Frosch
Publisher : Springer Science & Business Media
ISBN 13 : 354031301X
Total Pages : 1127 pages
Book Rating : 4.5/5 (43 download)

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Book Synopsis Contact Dermatitis by : Peter J. Frosch

Download or read book Contact Dermatitis written by Peter J. Frosch and published by Springer Science & Business Media. This book was released on 2006-06-07 with total page 1127 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is an unusual event for a textbook covering such a national and international networks and the use of highly specialized field as contact dermatitis to be standardized methodology, a highly differentiated published in its fourth edition within a time period picture can now be painted; we know the major p- of 13 years. When the European and Environmental fessions at risk, as well as the influences of age and Contact Dermatitis Research Group was founded in various cofactors. This is a solid basis for preventive 1985,one of the major goals was to edit a textbook of measures. A new allergen, described in one center, high scientific standard written by renown experts can now be tested on a large scale in a short time and keep it regularly updated. The greatest danger period. If the data evaluation shows an unacceptably for a textbook is to become outdated – then it stays high rate of sensitization in the exposed population, on the bookshelf and is rarely consulted. The contin- regulatory measures will be undertaken to protect uous flow of new medicaments, the fascinating the consumer. A recent example is the “methyldib- improvements in diagnostic image analysis and ever- mo glutaronitrile story. ” changing operative procedures are the reasons for These and other issues of importance are covered considerable knowledge deficits in old textbooks, in depth in the newest edition of this textbook.

Biopharmaceutics

Author : Hannah Batchelor
Publisher : John Wiley & Sons
ISBN 13 : 1119678285
Total Pages : 324 pages
Book Rating : 4.1/5 (196 download)

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Book Synopsis Biopharmaceutics by : Hannah Batchelor

Download or read book Biopharmaceutics written by Hannah Batchelor and published by John Wiley & Sons. This book was released on 2021-12-20 with total page 324 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explore the latest research in biopharmaceutics from leading contributors in the field In Biopharmaceutics - From Fundamentals to Industrial Practice, distinguished Scientists from the UK's Academy of Pharmaceutical Sciences Biopharmaceutica Focus Group deliver a comprehensive examination of the tools used within the field of biopharmaceutics and their applications to drug development. This edited volume is an indispensable tool for anyone seeking to better understand the field of biopharmaceutics as it rapidly develops and evolves. Beginning with an expansive introduction to the basics of biopharmaceutics and the context that underpins the field, the included resources go on to discuss how biopharmaceutics are integrated into product development within the pharmaceutical industry. Explorations of how the regulatory aspects of biopharmaceutics function, as well as the impact of physiology and anatomy on the rate and extent of drug absorption, follow. Readers will find insightful discussions of physiologically based modeling as a valuable asset in the biopharmaceutics toolkit and how to apply the principles of the field to special populations. The book goes on to discuss: Thorough introductions to biopharmaceutics, basic pharmacokinetics, and biopharmaceutics measures Comprehensive explorations of solubility, permeability, and dissolution Practical discussions of the use of biopharmaceutics to inform candidate drug selection and optimization, as well as biopharmaceutics tools for rational formulation design In-depth examinations of biopharmaceutics classification systems and regulatory biopharmaceutics, as well as regulatory biopharmaceutics and the impact of anatomy and physiology Perfect for professionals working in the pharmaceutical and biopharmaceutical industries, Biopharmaceutics - From Fundamentals to Industrial Practice is an incisive and up-to-date resource on the practical, pharmaceutical applications of the field.

Oral Bioavailability

Author : Xiaoling Li
Publisher : John Wiley & Sons
ISBN 13 : 1118067584
Total Pages : 875 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Oral Bioavailability by : Xiaoling Li

Download or read book Oral Bioavailability written by Xiaoling Li and published by John Wiley & Sons. This book was released on 2011-08-04 with total page 875 pages. Available in PDF, EPUB and Kindle. Book excerpt: Understand and assess the design, delivery, and efficacy of orally administered drugs A practical guide to understanding oral bioavailability, one of the major hurdles in drug development and delivery, Oral Bioavailability: Basic Principles, Advanced Concepts, and Applications is designed to help chemists, biologists, life science researchers, pharmaceutical scientists, pharmacologists, clinicians, and graduate and students become familiar with the fundamentals and practices of the science of oral bioavailability. The difference in rate and extent between a drug taken orally and the actual amount of a drug reaching the circulatory system, oral bioavailability is an essential parameter for determining the efficacy and adverse effects of new and developing medications, as well as finding an optimal dosing regimen. This book provides a much-needed one-stop resource to help readers better understand and appreciate the many facets and complex problems of oral bioavailability, including the basic barriers to oral bioavailability, the methods used to determine relevant parameters, and the challenges of drug delivery. In addition, this comprehensive book discusses biological and physicochemical methods for improving bioavailability, integrates physicochemistry with physiology and molecular biology, and includes several state-of-the-art technologies and approaches Caco-2 cell culture model, MDCK, and other related cell culture models which are used to study the science of oral bioavailability.

Percutaneous Penetration Enhancers Drug Penetration Into/Through the Skin

Author : Nina Dragicevic
Publisher : Springer
ISBN 13 : 3662532700
Total Pages : 414 pages
Book Rating : 4.6/5 (625 download)

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Book Synopsis Percutaneous Penetration Enhancers Drug Penetration Into/Through the Skin by : Nina Dragicevic

Download or read book Percutaneous Penetration Enhancers Drug Penetration Into/Through the Skin written by Nina Dragicevic and published by Springer. This book was released on 2017-05-04 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: Percutaneous Penetration Enhancers in a mini-series format comprising five volumes, represents the most comprehensive reference on enhancement methods – both well established and recently introduced – in the field of dermal/transdermal drug delivery. In detail the broad range of both chemical and physical methods used to enhance the skin delivery of drugs is described. All aspects of drug delivery and measurement of penetration are covered, and the latest findings are provided on skin structure and function, mathematics in skin permeation, and modern analytical techniques adapted to assess and measure penetration. In offering a detailed description of the methods currently in use for penetration enhancement, this book will be of value for researchers, pharmaceutical scientists, practitioners, students and dermatological scientists or dermatologists.

Dermatological Drug Development

Author : Tomoko Maeda-Chubachi
Publisher : Cambridge Scholars Publishing
ISBN 13 : 152755967X
Total Pages : 146 pages
Book Rating : 4.5/5 (275 download)

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Book Synopsis Dermatological Drug Development by : Tomoko Maeda-Chubachi

Download or read book Dermatological Drug Development written by Tomoko Maeda-Chubachi and published by Cambridge Scholars Publishing. This book was released on 2020-09-18 with total page 146 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book uniquely summarizes approaches to developing dermatological drugs in a regulated environment from the perspective of the pharmaceutical industry. It brings together the insights of skilled and experienced industry experts to reveal the complexities of dermatological drug development, covering topical, oral, and biologic drugs. This book fills an important gap, as there is currently no other textbook addressing dermatological drug development, explaining and illustrating why unique nonclinical and clinical studies are necessary and how they are typically designed and conducted. The drug development process is also an evolving strategy that is characterized by communicating, negotiating, and agreeing with regulatory agencies, such as FDA (US), EMA (EU), and PMDA (Japan).

Textbook of Contact Dermatitis

Author : R.J.G. Rycroft
Publisher : Springer Science & Business Media
ISBN 13 : 3662131196
Total Pages : 829 pages
Book Rating : 4.6/5 (621 download)

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Book Synopsis Textbook of Contact Dermatitis by : R.J.G. Rycroft

Download or read book Textbook of Contact Dermatitis written by R.J.G. Rycroft and published by Springer Science & Business Media. This book was released on 2013-12-01 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: Ideally every patient with eczema should be patch tested and the importance of this investigation is now universally accepted. The simplicity of the technique belies its many pitfalls, the greatest being to lack the knowledge required to select the correct allergens and to interpret the results. The introduction, nearly 20 years ago, of the journal Contact Dermatitis greatly stimulated the reporting of the clinical side of contact dermatitis but a vast amount of laboratory work has also been published in other journals on the mechanisms and theory of these reactions. The literature on the subject is now quite vast and a comprehensive book on the clinical and research aspects of contact dermatitis has been sorely needed. This textbook was carefully planned to gather together what is known of the subject into a cohesive whole and it has succeeded admirably. It consists of 22 chapters written by 41 contributors, each selected for their special study of particular subjects. Every feature of contact dermatitis has been covered, beginning with its history and even concluding with the names and addresses of those worldwide who have a specific interest in the subject. The text is illustrated and well laid out; it has been broken up into clearly demarcated sections making it easy to read and its information readily accessible. One's own writing concentrates the mind but editing the texts of authors from so many different countries was a task of considerable proportions.

FDA Bioequivalence Standards

Author : Lawrence X. Yu
Publisher : Springer
ISBN 13 : 1493912526
Total Pages : 472 pages
Book Rating : 4.4/5 (939 download)

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Book Synopsis FDA Bioequivalence Standards by : Lawrence X. Yu

Download or read book FDA Bioequivalence Standards written by Lawrence X. Yu and published by Springer. This book was released on 2014-09-05 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive reference provides an in-depth discussion on state-of-the-art regulatory science in bioequivalence. In sixteen chapters, the volume explores a broad range of topics pertaining to bioequivalence, including its origin and principles, statistical considerations, food effect studies, conditions for waivers of bioequivalence studies, Biopharmaceutics Classification Systems, Biopharmaceutics Drug Disposition Classification System, bioequivalence modeling/simulation and best practices in bioanalysis. It also discusses bioequivalence studies with pharmacodynamic and clinical endpoints as well as bioequivalence approaches for highly variable drugs, narrow therapeutic index drugs, liposomes, locally acting gastrointestinal drug products, topical products and nasal and inhalation products. FDA Bioequivalence Standards is written by FDA regulatory scientists who develop regulatory policies and conduct regulatory assessment of bioequivalence. As such, both practical case studies and fundamental science are highlighted in these chapters. The book is a valuable resource for scientists who work in the pharmaceutical industry, regulatory agencies and academia as well as undergraduate and graduate students looking to expand their knowledge about bioequivalence standards.

Dermatopharmacology of Topical Preparations

Author : B. Gabard
Publisher : Springer Science & Business Media
ISBN 13 : 364257145X
Total Pages : 470 pages
Book Rating : 4.6/5 (425 download)

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Book Synopsis Dermatopharmacology of Topical Preparations by : B. Gabard

Download or read book Dermatopharmacology of Topical Preparations written by B. Gabard and published by Springer Science & Business Media. This book was released on 2011-06-28 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proof of the efficacy of dermatological products is a prerequisite for clinical testing and registration. Now, efficacy claims for cosmetics must be equally substantiated. This book provides a concise, practical but comprehensive overview of experimental models used to screen, develop and select dermatological and cosmetic formulations. The authors are recognized specialists in their field and use a standardized approach to the projects facilitating the reading for the stressed scientist, for the R+D managers general view as well as for the beginners in the field.

Handbook of Bioequivalence Testing

Author : Sarfaraz K. Niazi
Publisher : CRC Press
ISBN 13 : 0849383595
Total Pages : 602 pages
Book Rating : 4.8/5 (493 download)

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Book Synopsis Handbook of Bioequivalence Testing by : Sarfaraz K. Niazi

Download or read book Handbook of Bioequivalence Testing written by Sarfaraz K. Niazi and published by CRC Press. This book was released on 2007-08-22 with total page 602 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct efficient and successful bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence, and advances in the analytical technology used to detect drug and metabolite levels have made

Handbook of Pharmaceutical Salts Properties, Selection, and Use

Author : P. Heinrich Stahl
Publisher : John Wiley & Sons
ISBN 13 : 9783906390581
Total Pages : 392 pages
Book Rating : 4.3/5 (95 download)

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Book Synopsis Handbook of Pharmaceutical Salts Properties, Selection, and Use by : P. Heinrich Stahl

Download or read book Handbook of Pharmaceutical Salts Properties, Selection, and Use written by P. Heinrich Stahl and published by John Wiley & Sons. This book was released on 2008-08-04 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive up-to-date guide and information source is an instructive companion for all scientists involved in research and development of drugs and, in particular, of pharmaceutical dosage forms. The editors have taken care to address every conceivable aspect of the preparation of pharmaceutical salts and present the necessary theoretical foundations as well as a wealth of detailed practical experience in the choice of pharmaceutically active salts. Altogether, the contributions reflect the multidisciplinary nature of the science involved in selection of suitable salt forms for new drug products.

Oral Drug Absorption

Author : Jennifer B. Dressman
Publisher : CRC Press
ISBN 13 : 1420077341
Total Pages : 432 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Oral Drug Absorption by : Jennifer B. Dressman

Download or read book Oral Drug Absorption written by Jennifer B. Dressman and published by CRC Press. This book was released on 2016-04-19 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral Drug Absorption, Second Edition thoroughly examines the special equipment and methods used to test whether drugs are released adequately when administered orally. The contributors discuss methods for accurately establishing and validating in vitro/in vivo correlations for both MR and IR formulations, as well as alternative approaches for MR an

Cosmetic Dermatology

Author : Zoe Diana Draelos
Publisher : John Wiley & Sons
ISBN 13 : 1118655486
Total Pages : 560 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Cosmetic Dermatology by : Zoe Diana Draelos

Download or read book Cosmetic Dermatology written by Zoe Diana Draelos and published by John Wiley & Sons. This book was released on 2015-10-08 with total page 560 pages. Available in PDF, EPUB and Kindle. Book excerpt: Back for a new edition, Zoe Draelos' outstanding resource to cosmetic dermatology again provides a highly-illustrated, clinical guide to the full range of cosmetic skin treatments. Bringing together experts from research, industry, surgery and practice, it is structured in four distinct parts for easy navigation by the busy clinician: Basic Concepts - giving an overview of the physiology pertinent to cosmetic dermatology and the delivery systems by which treatments can take effect; Hygiene Products - evaluating cleansing and moisturising products; Adornment - looking at aesthetic techniques such as cosmetics, nail protheses and hair treatment; Antiaging - ie, injectables, resurfacing and skin contouring techniques, and the rapidly growing area of Cosmeceuticals. With over 300 high-quality images and key summary boxes throughout, this new edition incorporates the newest procedural innovations in this rapidly developing field. Perfect for all dermatologists, especially those specialising in cosmetic dermatology and whether hospital-based or in private practice, it provides the complete cosmetic regimen for your patients and will be an indispensable tool to consult over and over again.

Bioequivalence Requirements in Various Global Jurisdictions

Author : Isadore Kanfer
Publisher : Springer
ISBN 13 : 3319680781
Total Pages : 345 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis Bioequivalence Requirements in Various Global Jurisdictions by : Isadore Kanfer

Download or read book Bioequivalence Requirements in Various Global Jurisdictions written by Isadore Kanfer and published by Springer. This book was released on 2017-12-05 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Jurisdictions is to attempt to gather the various BE requirements used in different global jurisdictions to provide a single source of relevant information. This information from, Brazil, Canada, China, European Union, India, Japan, MENA, Russia South Africa, the USA and WHO will be of value to drug manufacturers, regulatory agencies, pharmaceutical scientists and related health organizations and governments around the world in the quest to harmonize regulatory requirements for the market approval of generic products.