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Pharmaceutical Science & Regulation
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Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as …
Hardback
$169.95
PKPD awareness is vital if we are to attempt to relate preclinical results to the acute and long term consequences in humans. The debate on whether preclinical findings can be translated to the human usage is still engaging scientists across industry, academia and regulatory bodies. …
Hardback
$139.95
This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs. Coverage ranges from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years …
Hardback
$149.95
Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: …
Hardback
$139.95
This revised third edition has been updated to cover all aspects of chiral drugs from the academic, governmental, industrial, and clinical perspective reflecting the many advances in techniques and methodology. The title covers new material including the use of enzymes for the synthesis and …
Hardback
$239.95
Pharmacogenomics is the basis of personalized medicine, which is said to be the medicine of the future. The same pharmacogenomics principles that are applicable for therapeutic drugs are also applicable for drugs of abuse. Understanding genetic variation in alcohol response is vital for …
Hardback
$149.95
The regenerative capacity of the liver has been recognized for centuries, but when it is overwhelmed by insulting stimuli or is chronically damaged, its regenerative capability is substantially reduced or lost. Researchers have been working to find solutions to cure failing human liver function. …
Hardback
$99.95
Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been …
Hardback
$119.95
Knowledge of pharmacokinetics is critical to understanding the absorption, distribution, metabolism, and excretion of drugs. It is therefore vital to those engaged in the discovery, development, and preclinical and clinical evaluation of drugs, as well as practitioners involved in the clinical use …
Hardback
$89.95
Nonpharmacological treatments include a wide variety of treatments such as surgery, technical procedures, implantable and non-implantable devices, rehabilitation, psychotherapy, and behavioral interventions. Unlike pharmacological treatments, these have no specific requirements for approval. …
Hardback
$104.95
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Handbook of Analytical Validation
Pharmacogenomics of Alcohol and Drugs of Abuse
Basic Pharmacokinetics, Second Edition
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Journal of Biopharmaceutical Statistics
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