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Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. This book compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory documents. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. An edited book that is authored by leading experts ...
The Role of the Study Director in Nonclinical Studies
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Novel Immune Potentiators and Delivery Technologies for Next Generation Vaccines
Development of new-generation vaccines is now more challenging than ever, as identifying, purifying and evaluating vaccine antigens is a complex undertaking. Most importantly, once the relevant antigens have been identified, key focus then shifts to the development of suitable delivery systems and formulations to achieve maximum in vivo potency with minimum potential side effects. These novel formulations—many of which will be nanoparticulates—can deliver the antigens to the desired site, to the relevant antigen presenting cells, and prevent systemic exposure of the immune potentiators. The proposed book will outline all the critical steps that need to be considered for successful development of various types of nanoparticulate delivery systems for vaccine antigens. These contributions from leading experts in the area of vaccine formulation and delivery systems will tie in what is the most current status, including clinical evaluations with these novel vaccine technologies.
Polk City Directory
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Neoliberal Apartheid
This is the first comparative analysis of the political transitions in South Africa and Palestine since the 1990s. Clarno s study is grounded in impressive ethnographic fieldwork, taking him from South African townships to Palestinian refugee camps, where he talked to a wide array of informants, from local residents to policymakers, political activists, business representatives, and local and international security personnel. The resulting inquiry accounts for the simultaneous development of extreme inequality, racialized poverty, and advanced strategies for securing the powerful and policing the poor in South Africa and Palestine/Israel over the last 20 years. Clarno places these transition...
Nonclinical Development of Biologics, Vaccines and Specialty Biologics
Nonclinical Development of Biologics, Biosimilars, Vaccines and Specialty Biologics, Second Edition is a complete reference devoted to the nonclinical safety assessment of novel biopharmaceuticals, biosimilars, vaccines, cell and gene therapies and blood products. Updated and revised, the new edition compares and contrasts these types of biologics with one another and with small molecule drugs, while incorporating the most current and essential international regulatory guidelines. Each section discusses a different type of biologic, as well as early characterization strategies, principles of study design, preclinical pharmacokinetics and pharmacodynamics and preclinical assays. A multi-edite...
Except for Palestine
A bold call for the American Left to extend their politics to the issues of Israel-Palestine, from a New York Times bestselling author and an expert on U.S. policy in the region In this major work of daring criticism and analysis, scholar and political commentator Marc Lamont Hill and Israel-Palestine expert Mitchell Plitnick spotlight how holding fast to one-sided and unwaveringly pro-Israel policies reflects the truth-bending grip of authoritarianism on both Israel and the United States. Except for Palestine deftly argues that progressives and liberals who oppose regressive policies on immigration, racial justice, gender equality, LGBTQ rights, and other issues must extend these core princ...
Wildlife Toxicity Assessments for Chemicals of Military Concern
Wildlife Toxicity Assessments for Chemicals of Military Concern is a compendium of chemical-specific toxicity information with discussions on the rationale and development of Wildlife Toxicity Reference Values (TRVs) intended for use on terrestrial wildlife for risk assessment applications. Substances covered include military-related chemicals including explosives, propellants, pesticides and metals. Wildlife Toxicity Assessments for Chemicals of Military Concern is a much-needed resource designed to meet the needs of those seeking toxicological information for ecological risk assessment purposes. Each chapter targets a specific chemical and considers the current knowledge of the toxicological impacts of chemicals to terrestrial wildlife including mammalian, avian, amphibian and reptilian species. - Provides detailed information on how Wildlife Toxicity Values (TRVs) for military chemicals of concern are derived and evaluated. - Covers wildlife toxicity assessments of explosives, metals and environmental chemicals. - Compiles relevant information on the environmental effects of chemicals on wildlife in relation to public and environmental health.
