Pharmaceutical law

As many biological products face losing their patents in the next decade, the pharmaceutical industry needs an abbreviated regulatory pathway for approval of biosimilar drug products, which are cost-effective, follow-on/subsequent versions of the innovator's biologic products.

Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies.

As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed.

In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice.

Adaptive clinical trial designs, unlike traditional fixed clinical trial designs, enable modification of studies in response to the data generated in the course of the trial.

In response to the US FDA's Critical Path Initiative, innovative adaptive designs are being used more and more in clinical trials due to their flexibility and efficiency, especially during early phase development.

Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions.

It is estimated that 80 to 90% of drugs under development never make it to the marketplace due to insufficient clinical activity, unacceptable toxicity, rapid appearance of drug resistance, or other factors that should be, at least partially, predictable from preclinical testing.

Drug development is risky business.

A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective.

During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications.

During the last five years, clinical research and development costs have risen exponentially without a proportionate increase in the number of new medications.

Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies.

Patient self-reported data has become increasingly important in today's clinical trials.

Patient self-reported data has become increasingly important in today's clinical trials.

Clinical trials used to be conducted overwhelmingly in the US and Europe but for a range of economic, technical and ethical reasons, the number of multicentre studies recruiting subjects in different regions of the World has grown exponentially.

Clinical trials used to be conducted overwhelmingly in the US and Europe but for a range of economic, technical and ethical reasons, the number of multicentre studies recruiting subjects in different regions of the World has grown exponentially.

Biosimilars have the potential to change the way we think about, identify, and manage health problems.

Cluster Randomised Trials, Second Edition discusses the design, conduct, and analysis of trials that randomise groups of individuals to different treatments.

Statistical Testing Strategies in the Health Sciences provides a compendium of statistical approaches for decision making, ranging from graphical methods and classical procedures through computationally intensive bootstrap strategies to advanced empirical likelihood techniques.

Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies.

Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money.

Choosing the right contract research organization (CRO) can make the difference between getting a product to market quickly and cost-effectively, and wasting valuable time and money.

Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and Inferential Methods includes updates of established literature from the Wiley Encyclopedia of Clinical Trials as well as original material based on the latest developments in clinical trials.

A complete guide to the key statistical concepts essential for the design and construction of clinical trials As the newest major resource in the field of medical research, Methods and Applications of Statistics in Clinical Trials, Volume 1: Concepts, Principles, Trials, and Designs presents a timely and authoritative reviewof the central statistical concepts used to build clinical trials that obtain the best results.

Praise for the Second Edition: .

Everyone involved in pre-clinical, clinical, formulation, development and regulatory affairs will find Clinical Development a valuable resource.

Everyone involved in pre-clinical, clinical, formulation, development and regulatory affairs will find Clinical Development a valuable resource.

Clinical Data Quality Checks for CDISC Compliance using SAS is the first book focused on identifying and correcting data quality and CDISC compliance issues with real-world innovative SAS programming techniques such as Proc SQL, metadata and macro programming.

Clinical Data Quality Checks for CDISC Compliance using SAS is the first book focused on identifying and correcting data quality and CDISC compliance issues with real-world innovative SAS programming techniques such as Proc SQL, metadata and macro programming.

This book introduces bioengineers and students who must generate and/or report scientific data to the ethical challenges they will face in preserving the integrity of their data.

This book introduces bioengineers and students who must generate and/or report scientific data to the ethical challenges they will face in preserving the integrity of their data.

Globalizing Feminist Bioethics is a collection of new essays on the topic of international bioethics that developed out of the Third World Congress of the International Association of Bioethics in 1996.

Globalizing Feminist Bioethics is a collection of new essays on the topic of international bioethics that developed out of the Third World Congress of the International Association of Bioethics in 1996.

The world is awash in data.

The world is awash in data.

The exclusive, first-hand, behind-the-scenes story of how Pfizer raced to create the first Covid-19 vaccine, told by Pfizer's CEO Dr.

'A tour de force' - Patrick Radden Keefe, author of Empire of Pain From the doctor's office to the opioid crisis, The Hard Sell is the story of a pharmaceutical company that got Americans hooked on fentanyl - and how it was finally held to account.

Over 30,000 research articles have been retracted from peer-reviewed journals in recent years, exposing a troubling crisis in research integrity.

Over 30,000 research articles have been retracted from peer-reviewed journals in recent years, exposing a troubling crisis in research integrity.