Pharmaceutical Science

Drug Development

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Toxicologic Pathology: Nonclinical Safety Assessment

Pritam S. Sahota, James A. Popp, Jerry F. Hardisty, Chirukandath Gopinath
September 30, 2017

As drug development shifts over time to address unmet medical needs and more targeted therapies are developed, previously unseen pharmacological or off-target effects may occur in treatment. Designed to provide practical information for the bench toxicologic pathologist working in pharmaceutical...

Cancer Vaccines: From Research to Clinical Practice

Adrian Bot, Mihail Obrocea, Francesco M. Marincola
September 11, 2017

Recent advances in immunology and biology have opened new horizons in cancer therapy, included in the expanding array of cancer treatment options, which are immunotherapies, or cancer vaccines, for both solid and blood borne cancers. Cancer Vaccines: From Research to Clinical Practice is the first...

Targeted Delivery of Small and Macromolecular Drugs

Ajit S. Narang, Ram I. Mahato
July 26, 2017

Site-specific drug delivery and targeting attracts much research interest from both academia and industry, but because of the many challenges faced in the development of these systems, only a handful of targeted therapies have successfully made it into clinical practice. Focusing on the delivery...

New Generation Vaccines, Fourth Edition

Myrone M. Levine, Myron M. Levine, Gordon Dougan, Michael F. Good, Margaret A. Liu, Gary J. Nabel, James P. Nataro, Rino Rappuoli
July 13, 2017

Highlighting the latest activities and initiatives of prominent organizations working in the vaccine industry such as the Bill and Melinda Gates Foundation, The Global Alliance for Vaccines and Immunization, WHO, UNICEF, the World Bank, New Generation Vaccines, Fourth Edition, details steps...

Delivery Strategies for Antisense Oligonucleotide Therapeutics

Saghir Akhtar
July 13, 2017

With contributions from leading experts, this book is the first to focus solely on addressing the problems and reviewing the strategies currently being used to improve the delivery of antisense nucleic acids. Important delivery issues, such as improving biological stability, improving cell-specific...

Drug Repositioning: Approaches and Applications for Neurotherapeutics

Joel Dudley, Laura Berliocchi
June 30, 2017

Nervous system diseases represent a major health concern worldwide. Although important financial and professional investment, their etiology and pathophysiology still remain mostly elusive. Moreover, the clinical need of disease-modifying therapies is still unmet. In the last decades, traditional R...

Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development

Mariko Morishita, Kinam Park
June 16, 2017

Biodrug Delivery Systems: Fundamentals, Applications and Clinical Development presents the work of an international group of leading experts in drug development and biopharmaceutical science who discuss the latest advances in biodrug delivery systems and associated techniques. The book discusses...

Approaches to the Conformational Analysis of Biopharmaceuticals

Roger L. Lundblad
May 31, 2017

The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches...

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials

John O'Quigley, Alexia Iasonos, Björn Bornkamp
April 26, 2017

Handbook of Methods for Designing, Monitoring, and Analyzing Dose-Finding Trials gives a thorough presentation of state-of-the-art methods for early phase clinical trials. The methodology of clinical trials has advanced greatly over the last 20 years and, arguably, nowhere greater than that of...

Biosimilar Drug Product Development

Laszlo Endrenyi, Dr. Paul Declerck, Shein-Chung Chow
March 07, 2017

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug...

Methods in Comparative Effectiveness Research

Constantine Gatsonis, Sally C. Morton
February 07, 2017

Comparative effectiveness research (CER) is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care (IOM 2009). CER is conducted to develop evidence that...

Emerging Non-Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Harry Yang
December 01, 2016

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and...

Conferences

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