Overcoming Obstacles In Drug Discovery And Development

Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development. Provides real-world case studies in drug discovery and the development of drugs Illustrates the use of critical thinking and problem solving in approaching preclinical and clinical problems in drug discovery and development Illustrates and analyses examples of successes and failures in drug discovery and development that have not previously been reported

Overcoming Obstacles in Drug Discovery and Development: Surmounting the Insurmountable uses real-world case studies to illustrate how critical thinking and problem-solving skills are applied and necessary in the discovery and development of drugs. The book shows how the development of critical thinking to overcome issues plays an essential role in scientific and professional expertise. As addressing critical, unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills, this book is an ideal training manual on how to overcome obstacles. It will be essential to young scientists who want to develop the skills to successfully face challenges, learn from their mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from case studies of successful and unsuccessful drug development Provides real-world case studies in drug discovery and the development of drugs Illustrates the use of critical thinking and problem-solving in approaching preclinical and clinical problems in drug discovery and development Analyzes examples of successes and failures in drug discovery and development that have not previously been reported

This book is written to provide a brief overview concerning the latest drug discovery and its development based on the research studies that have been carried out until the present. The idea of preparing this book was inspired by the Holy Qur’an and the hadith, which guides us in all aspects of life, including disease management and treatment. This was supported by the traditional use of natural medicine by our ancestors. From the scientific point of view, we translate all those knowledge and information to be evidence-based modern medicines. We practised the common process of drug discovery development by identifying the potential molecule, followed by in vitro and in vivo experiments. The formulation is a crucial process to produce an efficient and effective drug delivery. Not to forget the future vision that “things would not give any meaning if it is not giving benefit to the people”. Commercialisation is one of the approaches to promote the product across the market and community. The book ends with the current issue of the COVID-19 global pandemic with regards to the treatment, natural medicine, and vaccination.

Introduction to Biological and Small Molecule Drug Research and Development provides, for the first time, an introduction to the science behind successful pharmaceutical research and development programs. The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches. The latter part of the book provides carefully selected real-life case studies illustrating how the theory presented in the first part of the book is actually put into practice. Studies include Herceptin/T-DM1, erythropoietin (Epogen/Eprex/NeoRecormon), anti-HIV protease inhibitor Darunavir, and more. Introduction to Biological and Small Molecule Drug Research and Development is intended for late-stage undergraduates or postgraduates studying chemistry (at the biology interface), biochemistry, medicine, pharmacy, medicine, or allied subjects. The book is also useful in a wide variety of science degree courses, in post-graduate taught material (Masters and PhD), and as basic background reading for scientists in the pharmaceutical industry. For the first time, the fundamental scientific principles of biopharmaceuticals and small molecule chemotherapeutics are discussed side-by-side at a basic level Edited by three senior scientists with over 100 years of experience in drug research who have compiled the best scientific comparison of small molecule and biopharmaceuticals approaches to new drugs Illustrated with key examples of important drugs that exemplify the basic principles of pharmaceutical drug research and development

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

??Applications of Artificial Intelligence in Healthcare and Biomedicine provides ?updated knowledge on the applications of artificial intelligence in medical image analysis. The book starts with an introduction to Artificial Intelligence techniques for Healthcare and Biomedicine. In 16 chapters it presents artificial applications in Electrocardiogram (ECG), Electroencephalogram (EEG) and Electromyography (EMG), signal analysis, Computed Tomography (CT), Magnetic Resonance Imaging (MR) and Ultrasound image analysis. It equips researchers with tools for early breast cancer detection from mammograms using artificial intelligence (AI), AI models to detect lung cancer using histopathological images and a deep learning-based approach to get a proper and faster diagnosis of the Optical Coherence Tomography (OCT) images. It also presents present 3D medical image analysis using 3D Convolutional Neural Networks (CNNs). Applications of Artificial Intelligence in Healthcare and Biomedicine closes with a chapter on AI-based approach to forecast diabetes patients' hospital re-admissions. This is a valuable resource for clinicians, researchers and healthcare professionals who are interested in learning more about the applications of Artificial Intelligence and its impact in medical/biomedical image analysis. Provides knowledge on Artificial Intelligence algorithms for clinical data analysis Gives insights into both AI applications in biomedical signal analysis, biomedical image analysis, and applications in healthcare, including drug discovery Equips researchers with tools for early breast cancer detection

There exists a profound conflict at the heart of oncology drug development. The efficiency of the drug development process is falling, leading to higher costs per approved drug, at the same time personalised medicine is limiting the target market of each new medicine. Even as the global economic burden of cancer increases, the current paradigm in drug development is unsustainable. In this book, we discuss the development of techniques in machine learning for improving the efficiency of oncology drug development and delivering cost-effective precision treatment. We consider how to structure data for drug repurposing and target identification, how to improve clinical trials and how patients may view artificial intelligence.

Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.