Ophthalmic Product Development

Author : Seshadri Neervannan,Uday B. Kompella
Publisher : Springer Nature
Page : 650 pages
File Size : 40,5 Mb
Release : 2022-03-11
Category : Medical
ISBN : 9783030763671

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Ophthalmic Product Development by Seshadri Neervannan,Uday B. Kompella Pdf

This is a comprehensive textbook addressing the unique aspects of drug development for ophthalmic use. Beginning with a perspective on anatomy and physiology of the eye, the book provides a critical appraisal of principles that underlie ocular drug product development. The coverage encompasses topical and intraocular formulations, small molecules and biologics (including protein and gene therapies), conventional formulations (including solutions, suspensions, and emulsions), novel formulations (including nanoparticles, microparticles, and hydrogels), devices, and specialty products. Critical elements such as pharmacokinetics, influence of formulation technologies and ingredients, as well as impact of disease conditions on products development are addressed. Products intended for both the front and the back of the eye are discussed with an eye towards future advances. @font-face {font-family:"Cambria Math"; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:roman; mso-font-pitch:variable; mso-font-signature:3 0 0 0 1 0;}@font-face {font-family:Calibri; panose-1:2 15 5 2 2 2 4 3 2 4; mso-font-charset:0; mso-generic-font-family:swiss; mso-font-pitch:variable; mso-font-signature:-469750017 -1073732485 9 0 511 0;}p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0cm; mso-pagination:widow-orphan; font-size:12.0pt; font-family:"Times New Roman",serif; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}.MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-family:"Calibri",sans-serif; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:Calibri; mso-fareast-theme-font:minor-latin; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-ansi-language:EN-US; mso-fareast-language:EN-US;}div.WordSection1 {page:WordSection1;}

Author : Uday B. Kompella,Henry F. Edelhauser
Publisher : Springer Science & Business Media
Page : 596 pages
File Size : 46,8 Mb
Release : 2011-08-03
Category : Medical
ISBN : 9781441999207

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Drug Product Development for the Back of the Eye by Uday B. Kompella,Henry F. Edelhauser Pdf

This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs. Specific topics covered in this book include: Solution, suspension, gel, nanoparticle, microparticle, and implant dosage forms Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering.

Author : Uday B. Kompella,Henry F. Edelhauser
Publisher : Springer
Page : 592 pages
File Size : 41,6 Mb
Release : 2011-08-09
Category : Medical
ISBN : 1441999213

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Drug Product Development for the Back of the Eye by Uday B. Kompella,Henry F. Edelhauser Pdf

This comprehensive volume discusses approaches for a systematic selection of delivery systems for various classes of therapeutic agents including small molecule, protein, and nucleic acid drugs. Specific topics covered in this book include: Solution, suspension, gel, nanoparticle, microparticle, and implant dosage forms Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering. Refillable and microneedle devices Intravitreal, suprachoroidal, intrascleral, transscleral, systemic, and topical routes of delivery Physical methods including iontophoresis for drug delivery Rational selection of routes of administration and delivery systems Noninvasive and continuous drug monitoring Regulatory path to drug product development Clinical endpoints for drug product development Emerging and existing drugs and drug targets Drug Product Development for the Back of the Eye is authored by renowned ocular drug delivery experts, representing academic, clinical, and industrial organizations and serves as indispensable resource for ophthalmic researchers, drug formulation scientists, drug delivery and drug disposition scientists, as well as clinicians involved in designing and developing novel therapeutics for the back of the eye diseases. This book is also relevant for students in various disciplines including ophthalmology, pharmaceutical sciences, drug delivery, and biomedical engineering.

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Page : 470 pages
File Size : 48,9 Mb
Release : 2019-12-04
Category : Science
ISBN : 9783527343966

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Innovative Dosage Forms by Yogeshwar Bachhav Pdf

Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Author : Frost Sullivan Staff
Publisher : Unknown
Page : 128 pages
File Size : 45,9 Mb
Release : 1996-09
Category : Electronic
ISBN : 0788905236

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World Ophthalmic Pharmaceutical Markets by Frost Sullivan Staff Pdf

Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
Publisher : Springer Science & Business Media
Page : 590 pages
File Size : 54,9 Mb
Release : 2013-10-12
Category : Medical
ISBN : 9781461479789

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Sterile Product Development by Parag Kolhe,Mrinal Shah,Nitin Rathore Pdf

This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.

Author : Sarwar Beg
Publisher : Springer Nature
Page : 190 pages
File Size : 54,9 Mb
Release : 2021-01-22
Category : Medical
ISBN : 9789813343511

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Design of Experiments for Pharmaceutical Product Development by Sarwar Beg Pdf

This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to dedicated case studies on various pharmaceutical experiments through illustrations, art-works, tables and figures. This book is a valuable guide for all academic and industrial researchers, pharmaceutical and biomedical scientists, undergraduate and postgraduate research scholars, pharmacists, biostatisticians, biotechnologists, formulations and process engineers, regulatory affairs and quality assurance personnel.

Author : Yashwant Pathak,Vijaykumar Sutariya,Anjali A. Hirani
Publisher : Springer
Page : 627 pages
File Size : 49,6 Mb
Release : 2016-11-12
Category : Medical
ISBN : 9783319293462

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Nano-Biomaterials For Ophthalmic Drug Delivery by Yashwant Pathak,Vijaykumar Sutariya,Anjali A. Hirani Pdf

This consolidated reference book addresses the various aspects of nano biomaterials used in ophthalmic drug delivery, including their characterization, interactions with ophthalmic system and applications in treatments of the ophthalmic diseases and disorders. In the last decade, a significant growth in polymer sciences, nanotechnology and biotechnology has resulted in the development of new nano- and bioengineered nano-bio-materials. These are extensively explored as drug delivery carriers as well as for implantable devices and scaffolds. At the interface between nanomaterials and biological systems, the organic and synthetic worlds merge into a new science concerned with the safe use of nanotechnology and nano material design for biological applications. For this field to evolve, there is a need to understand the dynamic forces and molecular components that shape these interactions. While it is impossible to describe with certainty all the bio physicochemical interactions at play at the interface, we are at a point where the pockets of assembled knowledge are providing a conceptual framework to guide this exploration, and review the impact on future product development. The book is intended as a valuable resource for academics and pharmaceutical scientists working in the field of polymers, polymers materials for drug delivery, drug delivery systems and ophthalmic drug delivery systems, in addition to medical and health care professionals in these areas.

Author : Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee
Publisher : CRC Press
Page : 433 pages
File Size : 46,5 Mb
Release : 2016-05-25
Category : Medical
ISBN : 9781498730785

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Pharmaceutical Product Development by Vandana B. Patravale,John I. Disouza,Maharukh Rustomjee Pdf

Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products. Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof. Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms. The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.

Author : Anonim
Publisher : Academic Press
Page : 976 pages
File Size : 43,9 Mb
Release : 2020-08-19
Category : Medical
ISBN : 9780128144565

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The Future of Pharmaceutical Product Development and Research by Anonim Pdf

The Future of Pharmaceutical Product Development and Research examines the latest developments in the pharmaceutical sciences, also highlighting key developments, research and future opportunities. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of the product development phase of drug discovery and drug development. Each chapter covers fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and the pharmaceutical industry. The book focuses on excipients, radiopharmaceuticals, and how manufacturing should be conducted in an environment that follows Good Manufacturing Practice (GMP) guidelines. Researchers and students will find this book to be a comprehensive resource for those working in, and studying, pharmaceuticals, cosmetics, biotechnology, foods and related industries. Provides an overview of practical information for clinical trials Outlines how to ensure an environment that follows Good Manufacturing Practice (GMP) Examines recent developments and suggests future directions for drug production methods and techniques

Author : Marc B. Brown,Adrian C. Williams
Publisher : CRC Press
Page : 248 pages
File Size : 50,5 Mb
Release : 2019-03-01
Category : Medical
ISBN : 9780429596063

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The Art and Science of Dermal Formulation Development by Marc B. Brown,Adrian C. Williams Pdf

The Art and Science of Dermal Formulation Development is a comprehensive guide to the theory and practice of transdermal and topical formulation development, covering preclinical studies, evaluation, and regulatory approval. It enables the reader to understand the opportunities and challenges in developing products and how risks can be mitigated. Over the last 25 years, expertise in this area has declined whilst drug delivery systems for other administration routes have developed significantly. The advantages offered by transdermal and topical drug delivery remain compelling for sectors including the pharmaceutical industry, personal care, and cosmetics. This text addresses the dearth of expertise and discusses how skin can be a route of delivery and the processes in formulation development, but how such an application is very different to that used for oral, IV, and other administration routes. Key Features: Presents a practical guide for both industry and academia Focuses on and draws together the fundamental principles behind transdermal and topical drug delivery Illustrates the practicalities of formulation design using key case studies Gives an understanding of the skin as a route of delivery and how formulation development for such application differs from that for other administration routes

Author : Neelesh Kumar Mehra,Arvind Gulbake
Publisher : CRC Press
Page : 326 pages
File Size : 40,5 Mb
Release : 2021-09-06
Category : Technology & Engineering
ISBN : 9781000421606

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Micro- and Nanotechnologies-Based Product Development by Neelesh Kumar Mehra,Arvind Gulbake Pdf

This book provides comprehensive information of the nanotechnology-based pharmaceutical product development including a diverse range of arenas such as liposomes, nanoparticles, fullerenes, hydrogels, thermally responsive externally activated theranostics (TREAT), hydrogels, microspheres, micro- and nanoemulsions and carbon nanomaterials. It covers the micro- and nanotechnological aspects for pharmaceutical product development with the product development point of view and also covers the industrial aspects, novel technologies, stability studies, validation, safety and toxicity profiles, regulatory perspectives, scale-up technologies and fundamental concept in the development of products. Salient Features: Covers micro- and nanotechnology approaches with current trends with safety and efficacy in product development. Presents an overview of the recent progress of stability testing, reverse engineering, validation and regulatory perspectives as per regulatory requirements. Provides a comprehensive overview of the latest research related to micro- and nanotechnologies including designing, optimisation, validation and scale-up of micro- and nanotechnologies. Is edited by two well-known researchers by contribution of vivid chapters from renowned scientists across the globe in the field of pharmaceutical sciences. Dr. Neelesh Kumar Mehra is working as an Assistant Professor of Pharmaceutics & Biopharmaceutics at the Department of Pharmaceutics, National Institute of Pharmaceutical Education & Research (NIPER), Hyderabad, India. He received ‘TEAM AWARD’ for successful commercialisation of an ophthalmic suspension product. He has authored more than 60 peer-reviewed publications in highly reputed international journals and more than 10 book chapter contributions. He has filed patents on manufacturing process and composition to improved therapeutic efficacy for topical delivery. He guided PhD and MS students for their dissertations/research projects. He has received numerous outstanding awards including Young Scientist Award and Team Award for his research output. He recently published one edited book, ‘Dendrimers in Nanomedicine: Concept, Theory and Regulatory Perspectives’, in CRC Press. Currently, he is editing books on nano drug delivery-based products with Elsevier Pvt Ltd. He has rich research and teaching experience in the formulation and development of complex, innovative ophthalmic and injectable biopharmaceutical products including micro- and nanotechnologies for regulated market. Dr. Arvind Gulbake is working as an Assistant Professor at the Faculty of Pharmacy, School of Pharmaceutical & Population Health Informatics, at DIT University, Dehradun, India. He has authored more than 40 peer-reviewed publications in highly reputed international journals, four book chapters and a patent contribution. He has received outstanding awards including Young Scientist Award and BRG Travel Award for his research. He is an assistant editor for IJAP. He guided PhD and MS students for their dissertations/research projects. He has successfully completed extramural project funded by SERB, New Delhi, Government of India. He has more than 12 years of research and teaching experience in the formulation and development of nanopharmaceuticals.

Author : Nikoletta Fotaki,Sandra Klein
Publisher : John Wiley & Sons
Page : 314 pages
File Size : 41,7 Mb
Release : 2019-10-11
Category : Science
ISBN : 9781118675830

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In Vitro Drug Release Testing of Special Dosage Forms by Nikoletta Fotaki,Sandra Klein Pdf

Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.

Author : Michael Kaschke,Karl-Heinz Donnerhacke,Michael Stefan Rill
Publisher : John Wiley & Sons
Page : 166 pages
File Size : 51,8 Mb
Release : 2014-03-17
Category : Science
ISBN : 9783527410682

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Optical Devices in Ophthalmology and Optometry by Michael Kaschke,Karl-Heinz Donnerhacke,Michael Stefan Rill Pdf

Optical Devices in Ophthalmology and Optometry Medical technology is a fast growing field. Optical Devices in Ophthalmology and Optometry gives a comprehensive review of modern optical technologies in ophthalmology and optometry alongside their clinical deployment. It bridges the technology and clinical domains and will be suitable in both technical and clinical environments. The book introduces and develops basic physical methods (in optics, photonics, and metrology) and their applications in the design of optical systems for use in ophthalmic medical technology. Medical applications described in detail demonstrate the advantage of utilizing optical-photonic methods. Exercises and solutions for each chapter help understand and apply basic principles and methods. From the contents: Structure and Function of the Human Eye Optics of the Human Eye Visual Disorders and Major Eye Diseases Introduction to Ophthalmic Diagnosis and Imaging Determination of the Refractive Status of the Eye Optical Visualization, Imaging, and Structural Analysis Optical Coherence Methods for Three-Dimensional Visualization and Structural Analysis Functional Diagnostics Laser???Tissue Interaction Laser Systems for Treatment of Eye Diseases and Refractive Errors

Author : James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Publisher : CRC Press
Page : 860 pages
File Size : 54,8 Mb
Release : 2019-12-13
Category : Medical
ISBN : 9781351625135

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Drug Discovery and Development, Third Edition by James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell Pdf

Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business