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Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development.Discusses differences in the work of a biostatistician in small pharma and big pharma.Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels.Describes some useful statistical background that can be capitalized upon in the drug development enterprise.Explains some hot topics and current trends in biostatistics in simple, non-technical terms.Discusses incompleteness of any system of standard operating procedures, rules and regulations.Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial.Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed.Discusses realistic planning of open-ended projects.

Mathematical and Statistical Skills in the Biopharmaceutical Industry : A Pragmatic Approach

"This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R &amp; D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.

Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials

The field of encapsulation, especially microencapsulation, is a rapidly growing area of research and product development. Applications of Encapsulation and Controlled Release offers a broad perspective on a variety of applications and processes, including, up-to-date research, figures, tables, illustrations, and references. Written at a level comprehensible to non-experts, it is a rich source of technical information and current practices in research and industry.

Applications of Encapsulation and Controlled Release

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systemsAnalyzes regulatory trends and expectationsIncludes approaches and practices used in the industry to comply with regulatory requirementsDiscusses recent worldwide supply chain issuesDelivers valuable information to a worldwide audience regarding the current GMP practices in the industry

Good Manufacturing Practices for Pharmaceuticals 7th Edition

Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration. Features: Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement It discusses the advantages of single-use process technologies and the qualification needs Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.

Filtration and Purification in the Biopharmaceutical Industry 3rd Edition

Cancer is a major healthcare burden across the world and impacts not only the people diagnosed with various cancers but also their families, carers, and healthcare systems. With advances in the diagnosis and treatment, more people are diagnosed early and receive treatments for a disease where few treatments options were previously available. As a result, the survival of patients with cancer has steadily improved and, in most cases, patients who are not cured may receive multiple lines of treatment, often with financial consequences for the patients, insurers and healthcare systems. Although many books exist that address economic evaluation, Economic Evaluation of Cancer Drugs using Clinical Trial and Real World Data is the first unified text that specifically addresses the economic evaluation of cancer drugs. The authors discuss how to perform cost-effectiveness analyses while emphasising the strategic importance of designing cost-effectiveness into cancer trials and building robust economic evaluation models that have a higher chance of reimbursement if truly cost-effective. They cover the use of real-world data using cancer registries and discuss how such data can support or complement clinical trials with limited follow up. Lessons learned from failed reimbursement attempts, factors predictive of successful reimbursement and the different payer requirements across major countries including US, Australia, Canada, UK, Germany, France and Italy are also discussed. The book includes many detailed practical examples, case studies and thought-provoking exercises for use in classroom and seminar discussions. Iftekhar Khan is a medical statistician and health economist and a lead statistician at Oxford Unviersity's Center for Statistics in Medicine. Professor Khan is also a Senior Research Fellow in Health Economics at University of Warwick and is a Senior Statistical Assessor within the Licensing Division of the UK Medicine and Health Regulation Agency. Ralph Crott is a former professor in Pharmacoeconomics at the University of Montreal in Quebec, Canada and former head of the EORTC Health Economics Unit and former senior health economist at the Belgian HTA organization. Zahid Bashir has over twelve years experience working in the pharmaceutical industry in medical affairs and oncology drug development where he is involved in the design and execution of oncology clinical trials and development of reimbursement dossiers for HTA submission

Economic Evaluation of Cancer Drugs : Using Clinical Trial and Real World Data

Cosmetics are the most widely applied products to the skin and include creams, lotions, gels and sprays. Their formulation, design and manufacturing ranges from large cosmetic houses to small private companies. This book covers the current science in the formulations of cosmetics applied to the skin. It includes basic formulation, skin science, advanced formulation, and cosmetic product development, including both descriptive and mechanistic content with an emphasis on practical aspects. Key Features: Covers cosmetic products/formulation from theory to practice Includes case studies to illustrate real-life formulation development and problem solving Offers a practical, user-friendly approach, relying on the work of recognized experts in the field Provides insights into the future directions in cosmetic product development Presents basic formulation, skin science, advanced formulation and cosmetic product development

Cosmetic Formulation : Principles and Practice

Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars

Biosimilarity : The Fda Perspective

Pharmacology Mind Maps is meant as a concise companion for the pharmacology students, enabling them to revise the subject in a short time through the innovative and effective technique of mind maps, after understanding the subject from a standard reference textbook. This handy manual provides the subject information in a condensed form, helping in last minute revision. Mind mapping is slowly taking over traditional methods and techniques and is explored extensively for a subject like pharmacology which is both an essential as well as a difficult subject to master for a medical student. This book will thus help the students to read, revise and recollect the subject easily and rapidly.

Pharmacology Mind Maps for Medical Students and Allied Health Professionals

The ocean is a source of unique natural products, mainly accumulated in living organisms. The c.4000 species of tunicates or sea squirts (Phylum, Chordata; Subphylum, Urochordata) are a high-potential yet under-studied source of bioactive compounds for pharmaceuticals. The secondary metabolites such as alkaloids isolated from these organisms have led to the discovery of an approved anti-tumor drug, anti-cancer drugs Yondelis (R) and Aplidin (R), as well as many others in clinical trial. There is an urgent need for more research on the bioactive compounds of marine tunicates and better knowledge about the identification and biology of these species. This is the first focused book to meet this need. The taxonomy, common name, global distribution, habitat, diagnostic features and pharmaceutical compounds (along with their activities) of 165 key species of tunicates are given, with high-quality illustrations. Contributed by scientists of both Marine Biology and Pharmacy disciplines, this book will serve as a standard reference for researchers, teachers and students of Fisheries Science, Marine Biology, Life Sciences, Biotechnology, Natural Products, and Pharmacy, and as a valuable guide for pharmaceutical companies involved in the development of new drugs from marine organisms.

Biology and Ecology of Pharmaceutical Marine Tunicates

Board Review Series Pharmacology 7th Edition South Asian Edition

Board Review Series Pharmacology 7th Edition South Asian Edition

This European Society of Cardiology (ESC) Handbook on Cardiovascular Pharmacotherapy has been developed by experts from the ESC Working Group on Cardiovascular Pharmacotherapy. Its recommendations are aligned with the ESC Clinical Practice Guidelines and based on the most recent scientific evidence in cardiovascular pharmacology and pharmacotherapy. The Handbook provides up-to-date information on pharmacotherapy for cardiovascular disease prevention, andtreatment of cardiovascular disease, including ischaemic heart disease, heart failure, arrhythmias, and structural heart disease. The Handbook also deals with the important problems of cardiovascular pharmacotherapy in pregnancy and lactation, kidney insufficiency, and liver disease as well as focusing on majordrug interactions, a topic of extreme importance in clinical practice. Two large sections of the book provide a comprehensive A-Z formulary of cardiac and non-cardiac pharmacological agents with practical and accessible information on the most important pharmacological aspects of these agents and their use in clinical practice. The Handbook represents essential reading for cardiologists, general practitioners, internal medicine specialists, anaesthetists, clinical pharmacologists, geriatricians, obstetricians, and cardiovascular nurse consultants. Junior doctors and trainees in all these specialties are also likely to find this book of help. The print edition comes with full access to the online version that will be updated at yearly intervals to keep it up to date.

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Pharmacology

Mathematical and Statistical Skills in the Biopharmaceutical Industry : A Pragmatic Approach

Innovative Strategies Statistical Solutions and Simulations for Modern Clinical Trials

Applications of Encapsulation and Controlled Release

Good Manufacturing Practices for Pharmaceuticals 7th Edition

Filtration and Purification in the Biopharmaceutical Industry 3rd Edition

Economic Evaluation of Cancer Drugs : Using Clinical Trial and Real World Data

Cosmetic Formulation : Principles and Practice

Biosimilarity : The Fda Perspective

Pharmacology Mind Maps for Medical Students and Allied Health Professionals

Biology and Ecology of Pharmaceutical Marine Tunicates

Board Review Series Pharmacology 7th Edition South Asian Edition

The Esc Handbook on Cardiovascular Pharmacotherapy