Ophthalmic Product Development

Ophthalmic Product Development

Author: Seshadri Neervannan

Publisher: Springer Nature

Published: 2022-03-11

Total Pages: 650

ISBN-13: 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;}


Drug Product Development for the Back of the Eye

Drug Product Development for the Back of the Eye

Author: Uday B. Kompella

Publisher: Springer Science & Business Media

Published: 2011-08-03

Total Pages: 596

ISBN-13: 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.


Drug Discovery and Development, Third Edition

Drug Discovery and Development, Third Edition

Author: James J. O'Donnell

Publisher: CRC Press

Published: 2019-12-13

Total Pages: 899

ISBN-13: 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


Ophthalmic Drug Delivery Systems

Ophthalmic Drug Delivery Systems

Author: Ashim K. Mitra

Publisher: CRC Press

Published: 2019-12-02

Total Pages: 847

ISBN-13: 9780367446765

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The second edition of this text assembles significant ophthalmic advances and encompasses breakthroughs in gene therapy, ocular microdialysis, vitreous drug disposition modelling, and receptor/transporter targeted drug delivery.


Practical Pharmaceutics

Practical Pharmaceutics

Author: Yvonne Bouwman-Boer

Publisher: Springer

Published: 2015-08-24

Total Pages: 873

ISBN-13: 3319158147

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This book contains essential knowledge on the preparation, control, logistics, dispensing and use of medicines. It features chapters written by experienced pharmacists working in hospitals and academia throughout Europe, complete with practical examples as well as information on current EU-legislation. From prescription to production, from usage instructions to procurement and the impact of medicines on the environment, the book provides step-by-step coverage that will help a wide range of readers. It offers product knowledge for all pharmacists working directly with patients and it will enable them to make the appropriate medicine available, to store medicines properly, to adapt medicines if necessary and to dispense medicines with the appropriate information to inform patients and caregivers about product care and how to maintain their quality. This basic knowledge will also be of help to industrial pharmacists to remind and focus them on the application of the medicines manufactured. The basic and practical knowledge on the design, preparation and quality management of medicines can directly be applied by the pharmacists whose main duty is production in community and hospital pharmacies and industries. Undergraduate as well as graduate pharmacy students will find knowledge and backgrounds in a fully coherent way and fully supported with examples.


Micro- and Nanotechnologies-Based Product Development

Micro- and Nanotechnologies-Based Product Development

Author: Neelesh Kumar Mehra

Publisher: CRC Press

Published: 2021-09-06

Total Pages: 582

ISBN-13: 1000422356

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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.


Ocular Drug Delivery Systems

Ocular Drug Delivery Systems

Author: Deepak Thassu

Publisher: CRC Press

Published: 2012-10-02

Total Pages: 461

ISBN-13: 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


Clinical Ocular Pharmacology

Clinical Ocular Pharmacology

Author: Jimmy D. Bartlett

Publisher: Butterworth-Heinemann

Published: 1995

Total Pages: 1080

ISBN-13:

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Written by experts in the field, this comprehensive resource offers valuable information on the practical uses of drugs in primary eye care. Discussions of the pharmacology of ocular drugs such as anti-infective agents, anti-glaucoma drugs, and anti-allergy drugs lead to more in-depth information on ocular drugs used to treat a variety of disorders, including diseases of the eyelids, corneal diseases, ocular infections, and glaucoma. The book also covers ocular toxicology, focusing on drug interactions, ocular effects of systemic drugs, and life-threatening systemic emergencies.


Nano-Biomaterials For Ophthalmic Drug Delivery

Nano-Biomaterials For Ophthalmic Drug Delivery

Author: Yashwant Pathak

Publisher: Springer

Published: 2016-11-12

Total Pages: 631

ISBN-13: 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.


A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

Author: Ali S. Faqi

Publisher: Elsevier

Published: 2024-02-11

Total Pages: 1074

ISBN-13: 0323984622

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A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. - Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy - Includes the latest international guidelines for nonclinical toxicology in both small and large molecules - Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology