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How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
  • Author : Bhavishya Mittal
  • Publisher :Unknown
  • Release Date :2016-10-05
  • Total pages :190
  • ISBN : 9780128047323
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Summary : 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

How to Integrate Quality by Efficient Design (QbED) in Product Development

How to Integrate Quality by Efficient Design (QbED) in Product Development
  • Author : Bhavishya Mittal
  • Publisher :Unknown
  • Release Date :2019-08-24
  • Total pages :274
  • ISBN : 9780128173046
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Summary : The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

An Industrial IoT Approach for Pharmaceutical Industry Growth

An Industrial IoT Approach for Pharmaceutical Industry Growth
  • Author : Valentina E. Balas,Vijender Kumar Solanki,Raghvendra Kumar
  • Publisher :Unknown
  • Release Date :2020-05-15
  • Total pages :382
  • ISBN : 9780128213278
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Summary : An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing. This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance. Emphasizes efficiency in pharmaceutical manufacturing through an IoT/Big Data approach Explores cutting-edge technologies through sensor enabled environments in the pharmaceutical industry Discusses system levels from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky,Harold S. Baseman
  • Publisher :Unknown
  • Release Date :2019-11-27
  • Total pages :298
  • ISBN : 9780128094464
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Summary : Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
  • Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
  • Publisher :Unknown
  • Release Date :2009-03-10
  • Total pages :978
  • ISBN : 008093272X
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Summary : Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms

The CDC Handbook - A Guide to Cleaning and Disinfecting Clean Rooms
  • Author : Dr. Tim Sandle
  • Publisher :Unknown
  • Release Date :2012-08-02
  • Total pages :300
  • ISBN : 9781781480809
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Summary : The Cleaning and Disinfection handbook is aimed at those working within the pharmaceutical and healthcare sectors around the world, as well as providing valuable information for students and for the general reader. The book provides comprehensive detail on different types of disinfectants and their modes of action; explains the problems of microbial destruction and resistance; introduces cleaning techniques and the latest safety regulations; expounds upon the application of cleaning within healthcare and pharmaceutical environments, noting current national and international standards. The book also provides guidance on disinfectant efficacy testing. Assembled by expert practitioners, the book balances theoretical concepts with sound practical advice, and is likely to become the definitive text on keeping contamination in control within clean areas and controlled environments. With this second edition, the book is fully updated in line with the latest standards and regulations.

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
  • Author : Lisa Plitnick,Danuta Herzyk
  • Publisher :Unknown
  • Release Date :2013-06-27
  • Total pages :432
  • ISBN : 9780123948236
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Summary : Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts in the field, this comprehensive reference provides critical insights to all researchers involved in early through late stage biologics. Provides in-depth coverage of the process of nonclinical safety assessment and comprehensive reviews of each type of biopharmaceutical Contains the most pertinent international regulatory guidance documents for nonclinical evaluation Covers early de-risking strategies and designs of safety assessment programs for novel biopharmaceuticals and vaccines, as well as follow-on biologics or "biosimilars" A multi-authored book with chapters written by qualified experts in their respective fields

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
  • Author : Kim Huynh-Ba
  • Publisher :Unknown
  • Release Date :2008-11-16
  • Total pages :389
  • ISBN : 9780387856278
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Summary : This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Modern Pharmaceutical Industry

Modern Pharmaceutical Industry
  • Author : Manager Us Regulatory Affairs Teva Neuroscience Thomas M Jacobsen,Thomas M. Jacobsen,Albert I. Wertheimer
  • Publisher :Unknown
  • Release Date :2010-10-25
  • Total pages :320
  • ISBN : 9781449618452
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Summary : Modern Pharmaceutical Industry: A Primer comprehensively explains the broad range of divisions in the complex pharmaceutical industry. Experts actively involved in each component discuss their own contribution to a pharmaceutical company's work and success. Divisions include regulatory affairs, research and development, intellectual property, pricing, marketing, generics, OTC, and more. The seventeen chapters included in this resource offer a wide range of topics, from discovery and formulation to post-approval and legal. Readers will be given a detailed look at the structure of a contemporary drug company and a thorough understanding of what goes on behind the scenes. Modern Pharmaceutical Industry: A Primer is a valuable resource for all pharmacy students, new hires at pharmaceutical companies, drug company management, and academic health center libraries. No other text provides a comprehensive look at one of the most dynamic industries related to the modern healthcare system.

Oral Controlled Release Formulation Design and Drug Delivery

Oral Controlled Release Formulation Design and Drug Delivery
  • Author : Hong Wen,Kinam Park
  • Publisher :Unknown
  • Release Date :2011-01-14
  • Total pages :376
  • ISBN : 1118060326
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Summary : This book describes the theories, applications, and challenges for different oral controlled release formulations. This book differs from most in its focus on oral controlled release formulation design and process development. It also covers the related areas like preformulation, biopharmaceutics, in vitro-in vivo correlations (IVIVC), quality by design (QbD), and regulatory issues.

Dosage Form Design Considerations

Dosage Form Design Considerations
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2018-07-28
  • Total pages :820
  • ISBN : 9780128144244
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Summary : 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

Pharmaceutical Preformulation and Formulation

Pharmaceutical Preformulation and Formulation
  • Author : Mark Gibson
  • Publisher :Unknown
  • Release Date :2016-04-19
  • Total pages :560
  • ISBN : 9781420073188
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Summary : Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the need for advanced information for drug preformulation and formulation and addresses the current trends in the continually evolving pharmaceutical industry. Topics include: Candidate drug selection Drug discovery and development Preformulation predictions and drug selections Product design to commercial dosage form Biopharmaceutical support in formulation Development The book is ideal for practitioners working in the pharmaceutical arena—including R&D scientists, technicians, and managers—as well as for undergraduate and postgraduate courses in industrial pharmacy and pharmaceutical technology.

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :2013-12-16
  • Total pages :744
  • ISBN : 9781118179796
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Summary : Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade

Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade
  • Author : World Intellectual Property Organization
  • Publisher :Unknown
  • Release Date :2013
  • Total pages :257
  • ISBN : 9789280523089
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Summary : This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.

Handbook of Pharmaceutical Wet Granulation

Handbook of Pharmaceutical Wet Granulation
  • Author : Ajit S. Narang,Sherif I.F. Badawy
  • Publisher :Unknown
  • Release Date :2018-08-31
  • Total pages :890
  • ISBN : 9780323481038
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Summary : Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Pharmaceutical Manufacturing Handbook

Pharmaceutical Manufacturing Handbook
  • Author : Shayne Cox Gad
  • Publisher :Unknown
  • Release Date :2008-04-04
  • Total pages :832
  • ISBN : 0470259825
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Summary : With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.

Handbook of Non-Invasive Drug Delivery Systems

Handbook of Non-Invasive Drug Delivery Systems
  • Author : Vitthal S. Kulkarni
  • Publisher :Unknown
  • Release Date :2009-12-31
  • Total pages :328
  • ISBN : 0815520263
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Summary : With the improvements in formulation science and certain transdermal delivery technologies, the non-invasive mode of drug delivery is now ready to compete with traditional methods of oral and injectible routes of drug delivery. The Handbook of Non-Invasive Drug Delivery Systems encompasses the broad field of non-invasive drug delivery systems that include drug delivery via topical, transdermal-passive, transdermal-active (device- aided enhanced penetration), trans-mucosal membrane, trans-ocular membrane as well as delivery via alveolar membrane from inhaled medication. Patient compliance has been found to be much higher when administrated by non-invasive routes and therefore they are considered to be a preferred mode of drug delivery. The book includes both science and technological aspects of new drug delivery systems. Its unique focus is that it is on new drug delivery systems that are considered to be "non-invasive". Other unique features include a chapter on Regulatory Aspects of non-invasive systems and one on FDA guidance for topical nano-drug delivery. Two chapters covering market trends and perspectives, as well as providing guidance to those marketing such systems are also included.

Commercializing Successful Biomedical Technologies

Commercializing Successful Biomedical Technologies
  • Author : Shreefal S. Mehta
  • Publisher :Unknown
  • Release Date :2008-04-24
  • Total pages :229
  • ISBN : 9781107394216
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Summary : Successful product design and development requires the ability to take a concept and translate the technology into useful, patentable, commercial products. This book guides the reader through the practical aspects of the commercialization process of drug, diagnostic and device biomedical technology including market analysis, product development, intellectual property and regulatory constraints. Key issues are highlighted at each stage in the process, and case studies are used to provide practical examples. The book will provide a sound road map for those involved in the biotechnology industry to effectively plan the commercialization of profitable regulated medical products. It will also be suitable for a capstone design course in engineering and biotechnology, providing the student with the business acumen skills involved in product development.

Dictionary of Pharmaceutical Medicine

Dictionary of Pharmaceutical Medicine
  • Author : Gerhard Nahler
  • Publisher :Unknown
  • Release Date :2013-06-29
  • Total pages :179
  • ISBN : 9783709140161
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Summary : This dictionary is aimed primarily at the beginners entering the new discipline of Pharmaceutical Medicine, an area comprising aspects of toxicology, pharmacology, pharmaceutics, epidemiology, statistics, drug regulatory and legal affairs, medicine and marketing. But also more experienced colleagues in departments engaged in clinical development as well as researchers and marketing experts in the pharmaceutical industry will find concise and up-to-date information. The book is completed by a list of a about 1000 abbreviations encountered in pharmaceutical medicine and a compilation of important addresses of national and international health authorities.

Pharmaceutical Facilities

Pharmaceutical Facilities
  • Author : Manohar A Potdar
  • Publisher :Unknown
  • Release Date :2014-11
  • Total pages :306
  • ISBN : 9385433768
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Summary : Designing, erection and commissioning of a pharmaceutical plant is a long drawn process. It needs basic understanding of pharmaceutical formulations and their logical and sequential processing. This whole process is tedious, time consuming and should have proper guidance in this regard. The book will provide such guidance which is a long felt need by the industry. Salient Features: - Pharmaceutical design aspects with sample layouts for all major formulations are discussed - All aspects related to project management, regulatory requirements, validation of facilities, HVAC and water system are discussed - A real handy book for all those who are involved in plant design, project management and facility and utilities validation in Pharmaceutical industry.

Long Acting Animal Health Drug Products

Long Acting Animal Health Drug Products
  • Author : Michael J. Rathbone,Arlene McDowell
  • Publisher :Unknown
  • Release Date :2012-10-11
  • Total pages :392
  • ISBN : 9781461444381
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Summary : Long acting veterinary formulations play a significant role in animal health, production and reproduction within the animal health industry. Such technologies offer beneficial advantages to the veterinarian, farmer and pet owner. These advantages have resulted in them growing in popularity in recent years. The pharmaceutical scientist is faced with many challenges when innovating new products in this demanding field of controlled release. This book provides the reader with a comprehensive guide on the theories, applications, and challenges associated with the design and development of long acting veterinary formulations. The authoritative chapters of the book are written by some of the leading experts in the field. The book covers a wide scope of areas including the market influences, preformulation, biopharmaceutics, in vitro drug release testing and specification setting to name but a few. It also provides a detailed overview of the major technological advances made in this area. As a result this book covers everything a formulation scientist in industry or academia, or a student needs to know about this unique drug delivery field to advance health, production and reproduction treatment options and benefits for animals worldwide.