This revised edition features contributions from leading cancer trial statisticians, providing expert insights into modern oncology trial design and methodology and provides a comprehensive resource for researchers, clinicians, and statisticians inv...Loe edasi...
This book provides an overview of drug development and regulatory affairs covering the lifecycle from discovery to market approval, global trade impacts, and regulatory frameworks. It explores clinical testing guidelines, bioethics, and pharmacovigi...Loe edasi...
This book examines application of medicinal compounds, focusing on bioactive substances, antioxidants, and advancement in drug development. It discusses role of nanotechnology and covers the extraction, profiling, and ADMET evaluation of medicinal c...Loe edasi...
This book covers the principles, methodology, and applications of network pharmacology in drug formulations, repurposing, formation and discovery, pharmacovigilance, and precision medicine, and presents the role of machine learning and AI in network...Loe edasi...
This book explores the therapeutic potential of Lupeol, focusing on its physico-chemical properties, chemical modifications, and managing various disorders, along with its antioxidant, anti-cancer properties, and future clinical prospects. It is a u...Loe edasi...
Provides timely information for toxicologic pathologists working in drug development. Concept chapters consolidated into two more concise chapters. Organ system chapters have more consistent commentary and guidance on molecular mechanism of action,...Loe edasi...
This book provides a comprehensive overview of the current trends, challenges, and opportunities in modernizing clinical trials, offering a roadmap for stakeholders in this evolving field. It provides actionable insights into the future of clinical...Loe edasi...
Today scientists are expected to be more accountable and transparent than at any time in history. Globally the pursuit of knowledge creation enjoys a place of distinction, and the public expects to reap considerable benefit from the innovative contr...Loe edasi...
This books covers all three types of trials resulting in clustered data. For outcome variables of binary, continuous, and time to event types. The methods are discussed in terms of clinical trials, but can be used to design and analyze any types of...Loe edasi...
This book provides a thorough reference on Good Clinical Practice (GCP) which is the international ethical, scientific and practical standard to which all clinical research is conducted....Loe edasi...
Written by leading pioneers of Bayesian clinical trial designs, this book explores the growing role of Bayesian thinking in clinical trial analysis. Covering Phase I, II, and III clinical trials, it establishes the basic principles before extending...Loe edasi...
Accessible to nonspecialists, this book explains the basic ideas in frailty modeling and statistical techniques, with a focus on real data application and interpretation of the results. It extensively explores how univariate frailty models can repre...Loe edasi...
This book discusses managing SOPs for GCP from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a users point of view to keep topics focus...Loe edasi...
This third edition contains new chapters on re-estimating sample size when testing for average bioequivalence, fitting a nonlinear dose response function, estimating a dose to take forward from phase two to phase three, establishing proof of concept...Loe edasi...
This book provides detailed concept and information on principles and processes of signal analysis in pharmacovigilance along with case studies. This book is useful for graduate, post graduate students of pharmaceutical sciences and scientists in ph...Loe edasi...
A Practical Guide to Clinical Data Management, Fourth Edition provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks....Loe edasi...
Studies of phenomena such as clinical trials usually focus on either the mechanisms involved in conducting or regulating operations at the global level, or ethical issues concerning the exploitation of individuals at the local level. In Pharmaceutic...Loe edasi...
Causal Inference in Pharmaceutical Statistics introduces the basic concepts and fundamental methods of causal inference relevant to pharmaceutical statistics. This book covers causal thinking for different types of commonly used study designs in the...Loe edasi...
This gives a comprehensive introduction to the (standard) statistical analysis based on the theory of martingales and develops entropy methods in order to treat dependent data in the framework of martingales. The author starts a summary of the marti...Loe edasi...
Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, statistical, and regulatory aspects of GTx development....Loe edasi...
