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.
Автор: Snitker Thomas Visby Название: User Research with Kids: How to Effectively Conduct Research with Participants Aged 3-16 ISBN: 1484270703 ISBN-13(EAN): 9781484270707 Издательство: Springer Рейтинг: Цена: 55890.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Preface An introduction to research with kids Chapter 1: Understanding kids and their experiences
Design, innovation and the need for research - and KX, Kids Experience
Play is a job to be done
What to expect when you're expecting ... kids for research
Kids research and rocket science
The status of children i n research and i n society - and i n your own mind
Kids: a very picky and playful audience - and research target
A spectrum of play - and a spectrum for research
A free-play research setup
A directed play research setup
A guided play - or games - research setup
(Section on kids development to follow here)
Global research with kids
Research with foreign kids means working with foreign adults
Selecting which cultures to study
Power distance
Individualism (vs. collectivism)
Masculinity (vs. femininity)
Uncertainty avoidance
Long-term orientation
Cognitive differences between Easterners and Westerners
Causal attribution
Categorization based on rules (Western) or relationship (Eastern)
Attention to the field (Eastern) or salient objects (Western)
Task-focus orientation (Western) and socioemotional relational orientation
(Eastern)
Chapter 2: How (not) to ruin perfectly good research in 18 steps
The bias chain - is bias a feature or a bug?
Bias in the scoping phase
For the right stakeholders or client
The right objective or problem or pain or goal
The right product or project
Selection bias
Bias during the preparation phase
The right participants, described i n the right terms
Sampling bias
Description bias
Descriptions i nherited from market research
Skill l evel as a descriptor
Staticity bias
The bias of gatekeepers and professional respondents
Doing the right things
Consensus bias
Right time of day or week or month
Right duration
Right l ocation/setting
Using the right device
Bias during the execution phase
Primed/instructed right
Primed/instructed i n the right amount
Moderated Right
Moderator Bias
Biased Questions
Leading Questions Bias
Misunderstood Question Bias
Unanswerable Question Bias
Metaphorically speaking
Question Order Bias
Biased Answers
Cognitive overload bias
Consistency Bias
Dominant Respondent Bias
Error Bias
Hostility Bias
Moderator Acceptance Bias (Acquiescence bias)
Mood Bias
Overstatement Bias
Reference Bias (Order Bias)
Sensitive i ssue Bias
Social Acceptance Bias
Sponsor Bias
The most dreaded answer: ' I don't know.'
Monitored by the right people
Bias during the analysis and reporting phase
Analysed right
Reported right
Biased Reporting
Positive reporting bias and Publication bias
Presented right
Hindsight bias
Sustained right
Actioned right
Bias is not a bug - i t's a feature
Further reading on bias
Chapter 3: Succeed through be
Автор: Haines Steven Название: The Product Manager`s Survival Guide: Everything You Need to Know to Succeed as a Product Manager ISBN: 1260135233 ISBN-13(EAN): 9781260135237 Издательство: McGraw-Hill Рейтинг: Цена: 25150.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Advance in your product management career and create innovative products that customers love! Regardless of industry or sector, to compete in today's business world, product managers must understand how their customer's preferences change, how technology evolves, and how to anticipate what competitors might do. You need a reliable resource that provides timely guidance and practical tools to help you compete. With new content and expert advice, this updated edition of The Product Manager's Survival Guide brings you fully up to date on what you need to succeed as a product manager. For your professional future, you'll learn it's not the development technique that will help you get ahead, it's how you think like a strategically minded business person. Your continuous learning starts with your product management acumen assessment, and takes root, when you develop your own professional development strategy. As you continue your career journey, you'll be able to become a member of the exclusive product management professional community (for readers of this book) at www.sequentlearning.com/community. The Product Manager's Survival Guide, Second Edition features brand new material, including: - A product management acumen assessment (https: //survey.sequentlearning.com/s3/PMAcumen) - Action planning ideas at the end of each chapter - Techniques to earn empowerment - Tools to develop product strategies and roadmaps - Methods to deploy and release products - Metrics to assess product performance Simple and easy to understand, this invaluable guide will help you bring your company into the digital age and continue to evolve with changing times.
Автор: Mario Vanhoucke Название: Integrated Project Management Sourcebook ISBN: 3319801244 ISBN-13(EAN): 9783319801247 Издательство: Springer Рейтинг: Цена: 186330.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This handbook is a unique,comprehensive resource for professional project managers and students inproject management courses that focuses on the integration between baselinescheduling, schedule risk analysis and project control, also known as DynamicScheduling or Integrated Project Management and Control.
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