[PDF] Ophthalmic Product Development eBook

Author : Seshadri Neervannan
Publisher : Springer Nature
Page : 650 pages
File Size : 23,92 MB
Release : 2022-03-11
Category : Medical
ISBN : 3030763676

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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
Publisher : Springer Science & Business Media
Page : 596 pages
File Size : 33,2 MB
Release : 2011-08-03
Category : Medical
ISBN : 1441999205

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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
Publisher : Springer
Page : 592 pages
File Size : 40,74 MB
Release : 2011-08-09
Category : Medical
ISBN : 9781441999214

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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 : Yashwant Pathak
Publisher : Springer
Page : 631 pages
File Size : 42,80 MB
Release : 2016-11-12
Category : Medical
ISBN : 331929346X

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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 : James J. O'Donnell
Publisher : CRC Press
Page : 860 pages
File Size : 46,85 MB
Release : 2019-12-13
Category : Medical
ISBN : 1351625136

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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

Author : Parag Kolhe
Publisher : Springer Science & Business Media
Page : 590 pages
File Size : 43,11 MB
Release : 2013-10-12
Category : Medical
ISBN : 1461479789

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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 : Peter Edman
Publisher : CRC Press
Page : 230 pages
File Size : 24,11 MB
Release : 2019-08-15
Category : Medical
ISBN : 1000696855

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A significant new book on drug delivery to the eye Biopharmaceutics of Ocular Drug Delivery examines the current physiological, anatomical, pharmaceutical/technological, and biopharmaceutical knowledge on ocular drug delivery. Leading ophthalmic researchers cover topics such as the formulation and usage of ophthalmic solutions and suspensions, the influence of surfactants and preservatives on ocular drug absorption, and new techniques that include bioadhesion and the use of hyaluronic acid as an ophthalmic vehicle. Promising research on new delivery systems for improved drug therapy is highlighted, including new pharmaceutical vehicles, inserts, liposomes, nanoparticles, and prodrugs. Biopharmaceutics of Ocular Drug Delivery is one of the few books available on drug delivery to the eye and will be an important reference for ophthalmologists, pharmacologists, pharmaceutical researchers, and other scientists interested in the topic.

Author : Deepak Thassu
Publisher : CRC Press
Page : 461 pages
File Size : 15,82 MB
Release : 2012-10-02
Category : Medical
ISBN : 1439848017

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Drug discovery for ocular diseases has taken great strides in the last two decades. From cornea to choroid, new drugs have been formulated to address a great variety of ocular diseases. Yet without good drug delivery systems, these drugs are less effective than they might be or could even cause serious side effects. Ocular Drug Delivery Systems: Ba