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Author: Anurag S. Rathore
Publisher: John Wiley & Sons
ISBN: 1118210913
Category : Science
Languages : en
Pages : 279
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Book Description
The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Author: Anurag S. Rathore
Publisher: John Wiley & Sons
ISBN: 1118210913
Category : Science
Languages : en
Pages : 279
Get Book Here
Book Description
The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.
Author: Paul Faya
Publisher: CRC Press
ISBN: 1000824772
Category : Mathematics
Languages : en
Pages : 354
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Book Description
The subject of this book is applied Bayesian methods for chemistry, manufacturing, and control (CMC) studies in the biopharmaceutical industry. The book has multiple authors from industry and academia, each contributing a case study (chapter). The collection of case studies covers a broad array of CMC topics, including stability analysis, analytical method development, specification setting, process development and optimization, process control, experimental design, dissolution testing, and comparability studies. The analysis of each case study includes a presentation of code and reproducible output. This book is written with an academic level aimed at practicing nonclinical biostatisticians, most of whom have graduate degrees in statistics. • First book of its kind focusing strictly on CMC Bayesian case studies • Case studies with code and output • Representation from several companies across the industry as well as academia • Authors are leading and well-known Bayesian statisticians in the CMC field • Accompanying website with code for reproducibility • Reflective of real-life industry applications/problems
Author: Taylor Warfield
Publisher:
ISBN: 9781545261828
Category : Business consultants
Languages : en
Pages : 0
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Book Description
To land a management consulting job at any of the top firms, including McKinsey, BCG, Bain, Deloitte, L.E.K., Oliver Wyman and Accenture, you must get through several rounds of case interviews. Whether your interview is in a few weeks or even tomorrow, this book is written to get you the maximum amount of knowledge in the least amount of time. I cut out all of the filler material that some other consulting books have, and tell you everything that you need to know in a clear and direct way. With this shortcut guide, you will: Understand and become proficient at the nine different parts of a case interview, and know exactly what to say and do in each step Learn the only framework strategy that you need to memorize to craft unique and tailored frameworks for every possible case scenario Gain knowledge of basic business terms and principles so that you can develop an astute business intuition Acquire the skills to solve any market sizing or other quantitative problem Uncover how to differentiate yourself from the thousands of other candidates who are fighting to get the same job you are Practice your case interview skills with included practice cases and sample answers Also visit HackingTheCaseInterview.com for a one-week online crash course to pass your upcoming interview.
Author: Bernd Meibohm
Publisher: John Wiley & Sons
ISBN: 3527609520
Category : Science
Languages : en
Pages : 426
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Book Description
This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.
Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470595876
Category : Science
Languages : en
Pages : 986
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Book Description
A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.
Author: Frank David
Publisher:
ISBN: 9780998407524
Category :
Languages : en
Pages :
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Book Description
A comprehensive primer to help non-experts evaluate clinical studies of new therapies. If you work in or around biotech, you're supposed to understand clinical trial results. But what if you're not an expert in study design or biostatistics? You may feel out of your comfort zone when faced with a journal article, press release, or investor presentation. Inside this book: -- Structured roadmap for assessing the main components of a planned orcompleted biotech trial.-- Clear explanations of the most common concepts and terms in biotechclinical studies, illustrated with over 100 real-world examples.-- Deep dives on essential topics like p values, sample size calculations, andKaplan-Meier curves, written in plain English for non-statisticians.-- Pointers for interpreting positive and negative study results, understandingcommon figures and tables, and identifying red flags in press releases.If you're a biotech executive, investor, advisor, or entrepreneur--or aspire to be one--this handbook will give you the foundation you need to analyze planned and completed clinical trials with more confidence."Hugely helpful. I wish I'd had a book like this earlier in my career." - SIR MENEPANGALOS, Executive VP, Biopharmaceuticals R&D, AstraZeneca"A terrific primer for non-experts looking to better evaluate new therapies." -DAPHNE ZOHAR, Founder and CEO, PureTech Health"Crisp and clear. Wise advice on when to rely on clinical data and when to beskeptical." - MICHAEL ROSENBLATT, Senior Partner, Flagship Pioneering"A source of much-needed illumination." - DAN LEPANTO, Senior ManagingDirector, M&A, SVB Leerink
Author: Mickey C. Smith
Publisher: CRC Press
ISBN: 9781439810910
Category : Medical
Languages : en
Pages : 444
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Book Description
Reflecting the fascinating and dramatic changes in pharmacy, pharmaceutical education, and the pharmaceutical industry in recent years, this authoritative volume focuses on the practice of marketing both prescription and nonprescription medications. In a dozen comprehensive chapters, author Mickey Smith highlights the economic social, and
Author: Gary P. Pisano
Publisher: Harvard Business Press
ISBN: 9781591398400
Category : Business & Economics
Languages : en
Pages : 278
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Book Description
Why has the biotechnology industry failed to perform up to expectations? This book attempts to answer this question by providing a critique of the industry. It reveals the causes of biotech's problems and offers an analysis on how the industry works. It also provides prescriptions for companies, seeking ways to improve the industry's performance.
Author: Joy A. Cavagnaro
Publisher: John Wiley & Sons
ISBN: 1118679385
Category : Medical
Languages : en
Pages : 1012
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Book Description
"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies." —From the Afterword by Anthony D. Dayan Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel.
Author: John Geigert
Publisher: Springer Nature
ISBN: 3031319095
Category : Science
Languages : en
Pages : 597
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Book Description
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
