Dosage Form Design Considerations

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Dosage Form Design Considerations

Anonim
Dosage Form Design Considerations Book PDF

Author : Anonim
Publisher : Academic Press
Page : 820 pages
File Size : 45,6 Mb
Release : 2018-07-28
Category : Medical
ISBN : 9780128144244

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Dosage Form Design Considerations by Anonim Pdf

Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Dosage Form Design Parameters

Anonim
Dosage Form Design Parameters Book PDF

Author : Anonim
Publisher : Academic Press
Page : 810 pages
File Size : 52,9 Mb
Release : 2018-07-25
Category : Medical
ISBN : 9780128144220

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Dosage Form Design Parameters by Anonim Pdf

Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Innovative Dosage Forms

Yogeshwar Bachhav
Innovative Dosage Forms Book PDF

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
Page : 470 pages
File Size : 47,5 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.

FASTtrack Pharmaceutics Dosage Form and Design, 2nd edition

David S. Jones
FASTtrack Pharmaceutics Dosage Form and Design 2nd edition Book PDF

Author : David S. Jones
Publisher : Pharmaceutical Press
Page : 433 pages
File Size : 41,7 Mb
Release : 2016-06-13
Category : Medical
ISBN : 9780857110787

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FASTtrack Pharmaceutics Dosage Form and Design, 2nd edition by David S. Jones Pdf

FASTtrack Pharmaceutics – Dosage Form and Design focuses on what you really need to know in order to pass your pharmacy exams. It provides concise, bulleted information, key points, tips and an all-important self-assessment section, including MCQs.

Handbook of Pharmaceutical Salts Properties, Selection, and Use

P. Heinrich Stahl
Handbook of Pharmaceutical Salts Properties Selection and Use Book PDF

Author : P. Heinrich Stahl
Publisher : John Wiley & Sons
Page : 392 pages
File Size : 55,9 Mb
Release : 2008-08-04
Category : Medical
ISBN : 3906390586

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Handbook of Pharmaceutical Salts Properties, Selection, and Use by P. Heinrich Stahl Pdf

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.

How to Develop Robust Solid Oral Dosage Forms

Bhavishya Mittal
How to Develop Robust Solid Oral Dosage Forms Book PDF

Author : Bhavishya Mittal
Publisher : Academic Press
Page : 190 pages
File Size : 43,7 Mb
Release : 2016-10-05
Category : Medical
ISBN : 9780128047323

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How to Develop Robust Solid Oral Dosage Forms by Bhavishya Mittal Pdf

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

Pharmaceutical Quality by Design

Sarwar Beg,Md Saquib Hasnain
Pharmaceutical Quality by Design Book PDF

Author : Sarwar Beg,Md Saquib Hasnain
Publisher : Academic Press
Page : 448 pages
File Size : 42,6 Mb
Release : 2019-03-27
Category : Business & Economics
ISBN : 9780128163726

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Pharmaceutical Quality by Design by Sarwar Beg,Md Saquib Hasnain Pdf

Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Sample Preparation of Pharmaceutical Dosage Forms

Beverly Nickerson
Sample Preparation of Pharmaceutical Dosage Forms Book PDF

Author : Beverly Nickerson
Publisher : Springer Science & Business Media
Page : 400 pages
File Size : 43,9 Mb
Release : 2011-08-05
Category : Medical
ISBN : 9781441996312

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Sample Preparation of Pharmaceutical Dosage Forms by Beverly Nickerson Pdf

This book is intended to serve as a resource for analysts in developing and troubleshooting sample preparation methods. These are critical activities in providing accurate and reliable data throughout the lifecycle of a drug product. This book is divided into four parts: • Part One covers dosage form and diluent properties that impact sample preparation of pharmaceutical dosage forms and the importance of sampling considerations in generating data representative of the drug product batch. • Part Two reviews specific sample preparation techniques typically used with pharmaceutical dosage forms. • Part Three discusses sample preparation method development for different types of dosage forms including addressing drug excipient interactions and post extraction considerations, as well as method validation and applying Quality by Design (QbD) principles to sample preparation methods. • Part Four examines additional topics in sample preparation including automation, investigating aberrant potency results, green chemistry considerations for sample preparation and the ideal case where no sample preparation is required for sample analysis.

The Future of Pharmaceutical Product Development and Research

Anonim
The Future of Pharmaceutical Product Development and Research Book PDF

Author : Anonim
Publisher : Academic Press
Page : 976 pages
File Size : 52,9 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

Biopharmaceutics and Pharmacokinetics Considerations

Anonim
Biopharmaceutics and Pharmacokinetics Considerations Book PDF

Author : Anonim
Publisher : Academic Press
Page : 754 pages
File Size : 51,5 Mb
Release : 2021-07-07
Category : Medical
ISBN : 9780128144268

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Biopharmaceutics and Pharmacokinetics Considerations by Anonim Pdf

Biopharmaceutics and Pharmacokinetics Considerations examines the history of biopharmaceutics and pharmacokinetics. The book provides a biopharmaceutics and pharmacokinetics approach to addressing issues in formulation development and ethical considerations in handling animals. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biopharmaceutics and pharmacokinetics within drug discovery and drug development. Each chapter delves into a particular aspect of this fundamental field to cover the principles, methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to study the chemical and physical properties of drugs and the biological effects they produce. Examines the most recent developments in biopharmaceutics and pharmacokinetics for pharmaceutical sciences Covers the principles, methodologies and technologies of biopharmaceutics and pharmacokinetics Focuses on the pharmaceutical sciences, but also encompasses aspects of toxicology, neuroscience, environmental sciences and nanotechnology

Pharmacokinetics and Toxicokinetic Considerations - Vol II

Rakesh Kumar Tekade
Pharmacokinetics and Toxicokinetic Considerations Vol II Book PDF

Author : Rakesh Kumar Tekade
Publisher : Academic Press
Page : 816 pages
File Size : 51,5 Mb
Release : 2022-02-05
Category : Business & Economics
ISBN : 9780323913164

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Pharmacokinetics and Toxicokinetic Considerations - Vol II by Rakesh Kumar Tekade Pdf

Pharmacokinetics and Toxicokinetic Considerations explains the central principles, cutting-edge methodologies, and incipient thought processes applied to toxicology research. As part of the Advances in Pharmaceutical Product Development and Research series, the book provides expert literature on dose, dosage regimen and dose adjustment, medication errors, and approaches for its prevention, the concept of pharmacotherapy, and managed care in clinical interventions. It expounds on strategies to revamp the pharmacokinetics of the drug and the factors affecting the stability of drugs and their metabolites in biological matrices. Finally, the book offers focused elaborations on various bioanalytical methods for bioavailability and bioequivalence assessment and integrates the wide-ranging principles and concepts shared by toxicokinetics and pharmacodynamics as mutual crosstalk rather than isolated observations. It will be helpful to researchers and advanced students working in the pharmaceutical, cosmetics, biotechnology, food, and related industries including toxicologists, pharmacists, and pharmacologists. Allows readers to systematically integrate up-to-date research findings into their laboratory work Presents focused explorations of bioanalytical methods for bioavailability and bioequivalence assessment Provides clinical applications of concepts

Dosage Forms, Formulation Developments and Regulations

Amit Kumar Nayak,Kalyan Kumar Sen
Dosage Forms Formulation Developments and Regulations Book PDF

Author : Amit Kumar Nayak,Kalyan Kumar Sen
Publisher : Elsevier
Page : 759 pages
File Size : 48,7 Mb
Release : 2023-12-09
Category : Medical
ISBN : 9780323972468

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Dosage Forms, Formulation Developments and Regulations by Amit Kumar Nayak,Kalyan Kumar Sen Pdf

Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. Examines trends and recent technologies in dosage, formulation and regulation Contains contributions from leading experts in academia, research, industry and regulatory agencies Includes high-quality illustrations, flow charts and tables for easy understanding of concepts Discusses practical examples and research case studies

Sterile Product Development

Parag Kolhe,Mrinal Shah,Nitin Rathore
Sterile Product Development Book PDF

Author : Parag Kolhe,Mrinal Shah,Nitin Rathore
Publisher : Springer Science & Business Media
Page : 590 pages
File Size : 55,6 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.

Biomaterials and Bionanotechnology

Anonim
Biomaterials and Bionanotechnology Book PDF

Author : Anonim
Publisher : Academic Press
Page : 724 pages
File Size : 44,7 Mb
Release : 2019-05-29
Category : Medical
ISBN : 9780128144282

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Biomaterials and Bionanotechnology by Anonim Pdf

Biomaterials and Bionanotechnology examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields. Examines the most recent developments in biomaterials and nanomaterials for pharmaceutical sciences Covers important topics, such as the fundamentals of polymers science, transportation and bio interaction of properties in nanomaterials across biological systems, and nanotechnology in tissue engineering as they pertain specifically to pharmaceutical sciences Contains extensive references for further discovery on the role of biomaterials and nanomaterials in the drug discovery process

Drug Formulation Design

Rahul Shukla,Aleksey Kuznetsov,Akbar Ali
Drug Formulation Design Book PDF

Author : Rahul Shukla,Aleksey Kuznetsov,Akbar Ali
Publisher : BoD – Books on Demand
Page : 330 pages
File Size : 48,9 Mb
Release : 2023-06-07
Category : Medical
ISBN : 9781837684717

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Drug Formulation Design by Rahul Shukla,Aleksey Kuznetsov,Akbar Ali Pdf

This book discusses the theoretical and practical aspects required to formulate conventional drug dosage forms and advanced technology-based therapeutics. It is organized into four sections: “Preformulation”, “Formulation Design and Approaches”, “Characterization and Analysis”, and “Cocrystal Engineering”. The approaches discussed enhance the overall quality of treatment and overcome the side effects of available therapies. The book is a collection of scholarly literature relevant to pharmaceutical technology and existing pharmaceutical technologies. It is a useful reference for industrial personnel working on developing novel pharmaceutical dosage forms.