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Preclinical Drug Development
Preclinical Drug Development, Second Edition discusses the broad and complicated realm of preclinical drug development. Topics range from assessment of pharmacology and toxicology to industry trends and regulatory expectations to requirements that support clinical trials. Highlights of the Second Edition include: PharmacokineticsModeling and simula
New Drug Approval Process
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include:advances in international regulatory requirements, including ICH guidelines and harmonizationa step-by-step
The Taft Court: Volume 10
This work will serve as the authoritative reference text on the Supreme Court during the period of 1921 to 1930, when William Howard Taft was Chief Justice. It will become a point of common reference across multiple disciplines, including history, law, and political science.
Environmental Monitoring for Cleanrooms and Controlled Environments
A critical technology in the science of contamination control, environmental monitoring is a technique that provides important data on the quality of a process, processing environment, and final product, which can aid scientists in identifying and eliminating potential sources of contamination in cleanrooms and controlled environments. In response
Filtration and Purification in the Biopharmaceutical Industry
Filtration and Purification in the Biopharmaceutical Industry, First Edition greatly expands its focus with extensive new material on the critical role of purification and the significant advances in filtration science and technology. This new edition provides state-of-the-science information on all aspects of filtration and purification, in
The Struggle and the Urban South
Through the example of Baltimore, Maryland, David Taft Terry explores the historical importance of African American resistance to Jim Crow laws in the South’s largest cities. Terry also adds to our understanding of the underexplored historical period of the civil rights movement, prior to the 1960s. Baltimore, one of the South largest cities, was a crucible of segregationist laws and practices. In response, from the 1890s through the 1950s, African Americans there (like those in the South’s other major cities) shaped an evolving resistance to segregation across three themes. The first theme involved black southerners’ development of a counter-narrative to Jim Crow’s demeaning doctrin...
Good Manufacturing Practices for Pharmaceuticals
With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
