"The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings's College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.

The stakes are high, time is of the essence and every detail matters - yet neonatal pharmacology often has been a challenging and poorly understood area of pediatrics. Until now. Many pharmacists working in hospital pharmacies today have little or no formal training in neonatology yet they are faced with dispensing medications to this fragile NICU population. NICU Primer for Pharmacists, by Amy P. Holmes, is a unique comprehensive overview of pharmacological treatment and neonatal care puts the information pharmacists, students, and residents need in one place, including strategies for: Selecting the optimal drug at the right dose within hours of recognizing a problem Detecting and correcting product dilutions Overseeing dosing adjustments as patients mature, increase or lose body weight Accommodating for multiple concurrent diseases, dramatic growth, organ maturation and damage and more Maximizing survival without serious long-term damage and neurodevelopmental delays. NICU Primer for Pharmacists puts the information you need in one place, so you can feel more confident making medication decisions for your tiniest patients. If your team cares for neonatal patients, consider this guide your invaluable resource for safe and effective drug therapy.

Patient safety is now a very strong focus of pharmacy degrees. Competency-based evaluations of pharmacy students using simulated assessments including Objective Structured Clinical Examinations (OSCEs) and Criterion Referenced Assessments (CRAs) are increasingly commonplace. These are designed to simulate aspects of real-life pharmacy practice in order to train students to integrate their knowledge of medicinal chemistry, pharmaceutics, therapeutics, legislation, clinical skills, numeracy, communication and empathy, and to test a student's ability to provide safe and effective patient care. This book provides a unique resource to support students and trainers in developing and practising these essential skills. It is designed as a useful resource for undergraduate students, clinical tutors and those involved in teaching students on pharmacy degree courses. Format OSCE outline Format (written/interactive) Level of difficulty Time limit Props supplied (e.g. BNF) Competencies tested Station task Model Answers and sample marking schemes Tips Short chapter introductions about how to tackle the type of problems encountered in the chapter. Station examples to test your ability to integrate knowledge and skills. Stations written in detail so that you can practise and then check or score performance against model answers. Examples of competency-based assessments designed to assess the level of integration between science and practice.

This is a companion self-study aid to Introduction to Pharmaceutical Calculations for practising calculations similar to those that may be presented in pharmacy examinations and in practice. Each section contains a variety of exercises which give the opportunity to practise calculations using the methods covered in Introduction to Pharmaceutical Calculations.

Handbook of Excipients The Handbook of Pharmaceutical Excipients is internationally recognised as the world's most authoritative source of information on pharmaceutical excipients. It is the definitive comprehensive guide to uses, properties and safety of excipients providing scientists and researchers with a one stop resource when researching an excipient. All of the 400+ monographs are also thoroughly cross-referenced and indexed to allow their identification by chemical, non-proprietary or trade names. Extensive content updates in the new edition include: - Over 420 fully referenced excipient monographs, many including IR, Raman, and NIR spectra - 13 new monographs including several amino acids and hydrated silicon dioxide - 250 existing monographs reviewed - New chapters providing support to the formulator, such as excipient selection for orally inhaled and also injectable formulations. Unique Benefits - The world's authoritative source of information on pharmaceutical excipients - International Scope: Recognized globally as the authority on the uses, properties and safety of excipients. - Written by over 170 expert pharmaceutical scientists - One stop resource when researching an excipient Contents - Biological Effects of Pharmaceutical Excipients - The Selection of Excipients for Injectable Formulations - The Selection of Excipients for Orally Inhaled Dosage Forms - The History of Excipients - The Use of Counterions and Coformers in the Creation of Salt and Co-Crystal forms of Active Pharmaceutical Ingredients (APIs) - Over 420 Monographs benefiting from a standardized, easy-to-use template including: - Pharmacopoeial information from the UK, Europe, Japan and the United States where relevant - non-proprietary names and synonyms - chemical name and structure, CAS Registry number, empirical formula, molecular weight - functional category, applications and incompatibilities - material description and typical excipient properties - safety, stability, storage and handling information - method of drug manufacture - related substances - primary references - editorial comments - author details and revision date

Offering a complete review of the basic mathematics concepts and skills, Pharmacy Calculations: An Introduction for Pharmacy Technicians, Second Edition provides students with the pharmacy basics necessary for correctly interpreting prescriptions and drug orders, and for performing dosing calculations that technicians face every day. The second edition has been streamlined to focus on the most important pharmacy calculation concepts-covering the fundamentals related to accuracy and basic math operations, units of measurement and conversions, critical thinking in problem solving, dosing calculations, percentages, concentration calculations, compounding formulas, intravenous infusion calculations, and business math. What's new in this edition? The chapters are broken down into four units and organized to complement most pharmacy technician training curricula and to support the ASHP-ACPE model curriculum: Review of Mathematics Systems of Measurement Preparing for Problem Solving in Pharmacy Dosing Calculations and other Pharmacy Problems Key features throughout the book include: Chapter objectives Key terms and definitions Examples of problem scenarios or calculations questions and solutions "Tech Note!" - provides a highlight of key points within the chapters "Numbers at Work" - illustrates why key concepts are important to know and skills are critical to master Practice problems Appendices that include the parts of a prescription, a glossary of terms, conversions, and abbreviations tables

In light of the recent emergence of Novel Psychoactive Substances (NPS) on a global scale, this book provides a timely analysis of the social and economic impact of the NPS phenomenon, and of the global policy and regulatory responses to it. It presents the first comprehensive overview of the international regulation, policy and market structure of the NPS phenomenon, offering a guide to inform legislative discussions and demonstrating from a comparative perspective the different approaches used to address the rise of NPS to date. It covers topics such as organized crime, drug markets, clinical evidence on NPS, and different regulatory approaches also in less explored settings such as prisons and sport environments. Overall, this highly informative and well-structured repository of different experiences with NPS policy, law and regulation offers an essential primary source of evidence for anyone interested in the area of drug and NPS policy, health economics and p ublic health.

This book describes the essential and cutting-edge concepts based on the frontier of pharmaceutical research in TCM, underlying scientific principles, and current advancements of drug delivery systems for Chinese medicines, including sustained-release drug delivery systems, trans-nasal drug delivery systems, dermal and transdermal drug delivery systems, etc. Novel carriers and emerging technologies (such as 3D printing) are also covered. The book provides readers with an overall picture of drug delivery systems for Chinese medicines and also yields benefits for the pharmaceutical industry with regard to TCM-based drug development.

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.

In medical and health care the scientific method is little used, and statistical software programs are experienced as black box programs producing lots of p-values, but little answers to scientific questions. The pocket calculator analyses appears to be, particularly, appreciated, because they enable medical and health professionals and students for the first time to understand the scientific methods of statistical reasoning and hypothesis testing. So much so, that it can start something like a new dimension in their professional world. In addition, a number of statistical methods like power calculations and required sample size calculations can be performed more easily on a pocket calculator, than using a software program. Also, there are some specific advantages of the pocket calculator method. You better understand what you are doing. The pocket calculator works faster, because far less steps have to be taken, averages can be used. The current nonmathematical book is complementary to the nonmathematical "SPSS for Starters and 2nd Levelers" (Springer Heidelberg Germany 2015, from the same authors), and can very well be used as its daily companion.

Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs. Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized. Addresses economic and practical considerations, unlike many other technical books. Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies. Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies

A textbook for undergraduate students consisting of case studies integrating practice and science.

This book is written for people working in primary care, who want to understand more about how they contribute to improving the health and health care of the populations that they serve, and for people working in public health, who want to understand the essential contribution of primary care to improving health. It sets out the nature, purpose and relevance of public health approaches to primary care practitioners and primary care organizations.
Primary care teams have had a long established role in public health, providing preventive services to populations, through the registered population in general practice. This model of a registered practice population has withstood multiple reconfigurations and reorganizations within the NHS and is the envy of many countries trying to create a public health system with primary care as its heart. There are clear differences in approach, with the inevitable conflicts between the rights of the individual set against the responsibility to ensure services are delivered fairly and equitably to whole populations. this book explores this dilemma, showing how people working in primary care can cross the divide to become part of the public health system, and in doing so are well placed to make a difference to the health of their populations.

This book elaborates on drug delivery targeting via intracellular delivery, specifically through the Receptor Mediated Endocytosis (RME) approach, due to the involvement of cellular receptors in various grave diseases. Targeted delivery relies on two basic approaches, passive and active targeting. While passive targeting approaches have shown great promise, the improved selectivity achieved with active targeting approaches has resulted in significantly higher efficacy. Interestingly there are numerous strategies for active targeting, many of which are already highlighted in , Targeted Drug Delivery: Concepts and Applications. Nevertheless an exciting and practical strategy for active targeting, which could enable high intracellular delivery, is through exploitation of RME. Cells in the body express receptors to enable various physiological and biochemical processes. As a result, many of these receptors are overexpressed in pathological conditions, or newer receptors expressed due to defective cellular functioning. RME is based on exploitation of such receptors to achieve intracellular delivery. While targeted delivery can have manifold applications, in this book we focus on two major and challenging therapeutic areas; i) Cancer and ii) Infectious Diseases. Targeted Intracellular Drug Delivery by Receptor Medicated Endocytosis discusses the major receptors that are useful for targeted delivery for these afflictions. A major section of this book is dedicated to details regarding their occurrence and location, the recognition domain of the receptor, structure activity relationship of substrate /ligand for selective binding, ligands explored, antagonists for ligand binding and relevance of these aspects for therapy of cancer and infectious diseases. These facets are elucidated with the help of specific examples from academic research and also emphasize commercial products, wherever relevant. In vitro cellular models relied on for assessing receptor mediated cellular targeting and in vivo models depicting clinical efficacy are focused on in a separate section. Finally, we briefly discuss the regulatory and toxicity issues that may be associated specifically with the RME approach of intracellular drug delivery.

This book is a compilation of the bench experience of leading experts from various research labs involved in the cutting edge area of research. The authors describe the use of stem cells both as part of the combinatorial therapeutic intervention approach and as tools (disease model) during drug development, highlighting the shift from a conventional symptomatic treatment strategy to addressing the root cause of the disease process. The book is a continuum of the previously published book entitled "Stem Cells: from Drug to Drug Discovery" which was published in 2017.