Adaptive Designs for Sequential Treatment Allocation presents a rigorous theoretical treatment of the results and mathematical foundation of adaptive design theory.
Interval-Censored Time-to-Event Data: Methods and Applications collects the most recent techniques, models, and computational tools for interval-censored time-to-event data.
If we will ever achieve Paul Ehrlich's "e;magic bullet,"e; that is, a molecule which goes with high selectivity to the therapeutic target site, does what it needs to do, and is subsequently cleared from the body, the practice of safety assessment will have to change.
This book provides a comprehensive understanding of streptomycetes, highlighting their various habitats, diversity, genetic structure, and metabolic engineering techniques to enhance the production of secondary metabolites.
As the pharmaceutical industry navigates this new era of technological innovation, the integration of AI, big data, and advanced analytics into clinical trials holds immense potential to transform drug development.
This concise text on biologically active substances of the food, pharmaceutical and agricultural industries presents data on natural compounds of vegetable and animal origin.
This book is intended to help decision-makers use, assess and appraise the evidence that underpins decisions about the use of therapeutic interventions.
Carbon-Based Nanocarriers for Drug Delivery enlists the latitudes and advancements in the synthesis processes, functionalization, and applications of carbon-based nanomaterials (CBNs) in targeted drug delivery systems (DDSs).
-Carbolines: A Privileged Scaffold for Modern Drug Discovery provides a summary of methods for the synthesis of various natural products engineered with the diverse -carboline scaffold and their biological evaluation.
A comprehensive exploration of the massive changes in the biopharmaceutical supply chain that have occurred during the past 10 years, and predicted future trends, Biopharmaceutical Supply Chains: Distribution, Regulatory, Systems and Structural Changes Ahead documents the specific impacts of these changes for key players in the supply chain.
A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today.
Addressing the many challenges that have arisen since the publication of its predecessor, this third edition covers the newest developments involved in the design and analysis of cancer clinical trials.
Design and Analysis of Cross-Over Trials is concerned with a specific kind of comparative trial known as the cross-over trial, in which subjects receive different sequences of treatments.
Many practitioners in the pharmaceutical industry are still largely unfamiliar with benefit-risk assessment, despite its growing prominence in drug development and commercialization.
Antibodies protect us from a wide range of infectious diseases and cancers and have become an indispensable tool in science-both for conventional immune response research as well as other areas related to protein identification analysis.
Advances in genomics and combinatorial chemistry during the past two decades inspired innovative technologies and changes in the discovery and pre-clinical development paradigm with the goal of accelerating the process of bringing therapeutic drugs to market.
As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed.
Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy.
The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products.
In clinical trial practice, controversial statistical issues inevitably occur regardless of the compliance with good statistical practice and good clinical practice.
Phage Display in Biotechnology and Drug Discovery, Second Edition provides a comprehensive view of the impact and promise of phage display in drug discovery and biotechnology.
Now that prohibitions against stem cell research are relaxing, it is time for the field to move forward with the advances that promise to eliminate so much human suffering.
Helping you become a creative, logical thinker and skillful "e;simulator,"e; Monte Carlo Simulation for the Pharmaceutical Industry: Concepts, Algorithms, and Case Studies provides broad coverage of the entire drug development process, from drug discovery to preclinical and clinical trial aspects to commercialization.
Extensively revised and updated, Antisense Drug Technology: Principles, Strategies, and Applications, Second Edition reflects the logarithmic progress made in the past four years of oligonucleotide-based therapies, and, in particular, antisense therapeutics and research.
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.
Although the genomic era is no longer in its infancy, the life sciences are still facing questions about the role of endogenous proteins and peptides in homeostasis and pathologies.
As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH).
Already popular in the analysis of medical device trials, adaptive Bayesian designs are increasingly being used in drug development for a wide variety of diseases and conditions, from Alzheimer's disease and multiple sclerosis to obesity, diabetes, hepatitis C, and HIV.
The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century.
Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies.
Oligonucleotides represent one of the most significant pharmaceutical breakthroughs in recent years, showing great promise as diagnostic and therapeutic agents for malignant tumors, cardiovascular disease, diabetes, viral infections, and many other degenerative disorders.
First introduced to biomedical research in 1980, the term biomarker has taken on a life of its own in recent years and has come to mean a number of things.
Colloidal drug delivery systems present a range of therapeutic benefits in the treatment of a number of challenging conditions, allowing researchers to cross barriers that have previously prevented efficient treatment while offering improved and more targeted absorption.