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Currently there are no process validation (PV) textbooks addressing the lifecycle concepts (Stage 1, 2, 3). Recent regulatory guidance's such as US FDA, EMEA, WHO, PIC/S have adopted the ICH lifecycle approach. The concepts are now harmonized across regulatory guidance's and organizations have an opportunity to align PV activities for all regulated markets. Therefore a need exists for consensus and direction on how to approach solid dose manufacturing process validation for regulatory compliance. Solid Dose Process Validation: The Basics, Volume One and companion Solid Dose Process Validation: Lifecycle Approach Application, Volume Two, also available as a set, provide directions and solutions for these unmet needs for the pharmaceutical industry. The topics and chapters give a systematic understanding for the application of lifecycle concepts in solid dose pharmaceutical manufacturing. All approaches meet the regulatory requirements enlisted in the guidance's, which is the precursor to applying the concepts. This set is published as a comprehensive solution for solid dose process validation. Since solid dose formulations encompass majority of the pharmaceutical preparations, it is essential information for pharmaceutical professionals who use the process validation lifecycle approach.

The purpose of this book is to give a concise introduction to development and analysis of pharmaceutical biologics for those in the pharmaceutical industry who are switching focus from small molecules to biologics processing, analysis, and delivery.

This first monograph in the new AAPS book series concisely reviews important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance.

Solid Oral Dose Process Validation, Lifecycle Approach: Application, Volume Two and the companion Volume One, Solid Dose Process Validation, The Basics, also available as a set, provide directions and solutions for the pharmaceutical industry.

Essential Pharmaceutics is suited to this modern teaching style, and is the first book of its kind to provide the resources and skills needed for successful implementation of an active learning pharmaceutics course.This text offers a format that is specifically suited for integration in an active learning, team-based classroom setting.

Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation.

As an academic or a small business owner, you will need to write grants at some point in your career. Writing them though is not enough, what you also need to know is how to win grants. Much has been written about writing grants, the mysterious special ability called ¿grantsmanship¿, so it occurred to me that there is a need to come at this differently and spill the beans. The difficulty in getting a grant, in particular an NIH grant like an R01 in the USA is often described, it is competitive and gets tougher every year. Your proposal therefore must stand out, it must connect with the reviewers. This is true for all types of grants, give the reviewer what they want always. But also, you need to connect to the program officer, the committee that ultimately makes funding decisions and you must take care of a myriad of other details outside of the main event which is describing the ¿science¿. This means you cannot rely on just out-writing the competition, it is more than that as you have to out-think, out-strategize and out-schmooze them. If you have been continually funded for decades that is terrific, but if you want to keep being funded there is no guarantee what got you there will keep you there. What was a hot technology 4-5 years ago is not the new thing anymore, you will need to do something different, but what? You therefore need to not only think about writing great grants, you need to put it into practice and win them. Having written and won grants from the NIH and DOD over the past 17 years (and longer by the time you read this) I possess a valuable perspective.Each grant and study section will be different. Whether a big or small grant it does not seem to make a difference the reviewers will critique your efforts, they may not like it, they may reject your ideas or they may love it. You have some small degree of control until the proposal leaves your hands or more correctly you click ¿submit¿. You will need to differentiate your grant from the hundreds of others in many ways, but you cannot change who you are, your history so how you describe yourself and team will also have an impact. You could spend hundreds of hours on your proposal or just a day and the outcome might still be the same. This small book is a summary of my own personal experiences and will provide some advice that will help you learn how to do a better job of winning grants.This book is written by a scientist who writes the grants and develops commercial products;Provides a unique perspective on what you need to write better grants;Teaches you how to continually win grants;This book provides examples from the authors own grant applications;The reader will be inspired to start a company to win small business grants.

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance.This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirementsof the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook¿s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.

Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.

Therapeutic macromolecules and biologics have gained increasing importance in the last decade. Pulmonary and intranasal delivery of these therapeutic modalities, which have poor oral bioavailability, could constitute an attractive, non-invasive alternative to parenteral delivery. They can be considered for either topical use for treating diseases affecting the airways or for systemic use for treating a variety of other diseases. Therefore, this book is a readable, thoughtful, and useful guide on the latest research developments and the best options that people involved with pulmonary and intranasal route of administration and biologically active agents can bring to their practices. Furthermore, it explores the underlying scientific rationale for the strategies applied to overcome drug delivery challenges and provides insights to inspire further research in this growing area.