AAPS Introductions in the Pharmaceutical Sciences – serie

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.

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.

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.

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.

This book provides a concise overview of recent advances in Pharmacokinetics (PK) and Pharmacodynamics (PD). The pharmacokinetics section covers the state of the art in Physiologically Based Pharmacokinetic (PBPK) modeling (Chapter 1) as well as the assessment of food effect on drug absorption using PBPK modeling (Chapter 2). Chapters 3 and 4 describe the recent development of Physiologically Based Finite Time Pharmacokinetic (PBFTPK) models and their applications to pharmacokinetic data. The pharmacodynamics section focuses on PK/PD modeling. Chapter 5 provides an overview of PK/PD modeling and simulation in clinical practice and studies. Chapter 6 deals with the subject/physiology variability issue encountered in PK/PD studies, while Chapter 7 reviews the influence of clinical pharmacology in the modernization of drug development and regulation. This book is an essential reference for pharmaceutical scientists.

The pharmacokinetics section covers the state of the art in Physiologically Based Pharmacokinetic (PBPK) modeling (Chapter 1) as well as the assessment of food effect on drug absorption using PBPK modeling (Chapter 2).

The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process.The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms.Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process.Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations.Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up.Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource forthose involved in the pharmaceutical industry.Only book that is dedicated to pharmaceutical process engineering and scale-up;Contain numerous case studies for easy reference;Covers solid, liquid, and advanced dosage forms.

The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process.The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms.Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process.Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations.Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up.Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource forthose involved in the pharmaceutical industry.Only book that is dedicated to pharmaceutical process engineering and scale-up;Contain numerous case studies for easy reference;Covers solid, liquid, and advanced dosage forms.

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.

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.

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations.

Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations.

New materials and manufacturing techniques are emerging with potential to address the challenges associated with the manufacture of pharmaceutical systems that will teach new tricks to old drugs. 3D printing (3DP) is a technique that can used for the manufacturing of dosage forms, and especially targeting paediatric and geriatric formulations, as permits the fabrication of high degrees of complexity with great reproducibility, in a fast and cost-effective fashion, and offers a new paradigm for the direct manufacture of personalised dosage forms. The book is covering the basics behind each additive manufacturing (AM) method, current applications in pharmaceutics for each 3DP method, and case studies (examples) from a teaching perspective, targeting undergraduate (UG) and postgraduate (PG) students. A unique to this book is the integration of studies based upon the use of different AM technologies, which designed to reinforce importance printing parameters and material considerations. The book includes case studies or multiple-choice questions (MCQs), which allow application of the content in a flipped-classroom.

New materials and manufacturing techniques are emerging with potential to address the challenges associated with the manufacture of pharmaceutical systems that will teach new tricks to old drugs.

This book is written to serve as textbook on biomaterials and biopolymers for faculty and students and thus  contains a broad introduction and basic terms, followed by major developments over the years with some emphasis on recent developments and future prospects. It provide a comprehensive overview in biomaterials and biopolymers. All relevant aspects of modern biomaterials, including: synthesis and characterization, biocompatibility and host response, the implementation of novel manufacturing processes, and advanced medical and biotechnological applications. Each chapter provides an overview of a specific field, its importance, the chemistry of biomaterials and the relations between chemical structure and the applications. Each chapter ends with a future prospective/concepts and a friendly quiz/multiple answer questions with answers that serves as a resource to provide guided additional practice.

This book is written to serve as textbook on biomaterials and biopolymers for faculty and students and thus contains a broad introduction and basic terms, followed by major developments over the years with some emphasis on recent developments and future prospects.

Pulmonary and intranasal delivery of these therapeutic modalities, which have poor oral bioavailability, could constitute an attractive, non-invasive alternative to parenteral delivery.

Pulmonary and intranasal delivery of these therapeutic modalities, which have poor oral bioavailability, could constitute an attractive, non-invasive alternative to parenteral delivery.

Particularly in healthcare fields, there is a growing movement away from traditional lecture style courses towards active learning and team-based activities to improve retention of concepts and build higher level thinking through the application of complex problems with a strong foundation of facts and data.

Particularly in healthcare fields, there is a growing movement away from traditional lecture style courses towards active learning and team-based activities to improve retention of concepts and build higher level thinking through the application of complex problems with a strong foundation of facts and data.

The book covers the basics of microfluidics, current applications in areas such as formulation, drug delivery, drug screening and development, monitoring and diagnostics, and case studies from a teaching perspective to undergraduate and postgraduate students, allowing application of the content in a flipped classroom.

The book covers the basics of microfluidics, current applications in areas such as formulation, drug delivery, drug screening and development, monitoring and diagnostics, and case studies from a teaching perspective to undergraduate and postgraduate students, allowing application of the content in a flipped classroom. Multiple choice questions are included at the end of each chapter. All chapter authors are pioneers and world leaders. This is an ideal book for students, researchers, and industry professionals working on microfluidics in the pharmaceutical sciences.

The book covers recent advances in the field of CNS therapeutics, including opportunities posed by expanding basic knowledge related to CNS conditions  and novel approaches for efficient drug delivery to the brain (e.g., pharmaceutical nanocarriers and transporter- and transcytosis-mediated drug delivery to the brain inhibition of the blood-brain barrier). Chapters dealing with state-of-the-art in silico and in vitro tools for predictive purposes related to CNS bioavailability are also be included.This is an ideal book for undergraduate students and graduates in the field of medicine and pharmaceutics, and professionals working in the field of brain disorders.