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Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.

Dedico este libro a la memoria de mi padre, Manuel Gobea Revelo, que falleció de cáncer de colon el día 24/11/2009.También quiero dedicar este libro a las personas que sufren un cáncer en general y a todas aquellas que se nos adelantaron en el camino.(A LA MEMORIA DE TODOS ELLOS)Con este testimonio, también quiero homenajear a todas las mujeres, que sufren esta enfermedad en el anonimato, a las que no son famosas ni salen en la televisión que ni siquiera son noticia.A las que tienen que darse sus tratamientos en las grandes salas masificadas de los grandes hospitales de la seguridad social, en los cuales, solo son un número de historial.A todas las que después de los tratamientos tan duros que reciben, llegan a sus casas con una sonrisa en la boca, y aun con lágrimas en los ojos, se las arreglan para decir" estoy bien" y siguen manteniendo en orden su vida.

Newbery Medal Winner * Teachers’ Top 100 Books for Children * ALA Notable Children’s Book Beverly Cleary’s timeless Newbery Medal-winning book explores difficult topics like divorce, insecurity, and bullying through the thoughts and emotions of a sixth-grade boy as he writes to his favorite author, Boyd Henshaw. After his parents separate, Leigh Botts moves to a new town with his mother. Struggling to make friends and deal with his anger toward his absent father, Leigh loses himself in a class assignment in which he must write to his favorite author. When Mr. Henshaw responds, the two form an unexpected friendship that will change Leigh’s life forever. From the beloved author of the Henry Huggins, Ramona Quimby, and Ralph S. Mouse series comes an epistolary novel about how to navigate and heal from life’s growing pains.

Second edition of Gloria Anzaldua's major work, with a new critical introduction by Chicano Studies scholar and new reflections by Anzaldua.

A los cincuenta años, la persona posee un mundo interior muy diferente del que poseía a los veinte. Se relaciona de otro modo consigo misma, su sexualidad es totalmente distinta y cambia su escala de valores en cuanto a carrera, familia y sociedad. El adulto es mucho más que un niño que creció. Es sorprendente que tan pocos estudios psicológicos se hayan dedicado a la edad madura. La terapia se interesa ante todo por la infancia y la proyecta sobre la madurez. A veces parece que la actitud de la psicología en este campo se limita a enumerar las funciones que van deteriorándose en el camino hacia la vejez. La mayoría de los individuos no son conscientes de las oportunidades de desarrollo continuo que tienen lugar en todas las edades, y del nuevo florecimiento que se produce en la segunda mitad de la vida. Cuando Edipo creció procura estimular la percepción de ese crecimiento, definir la singular cultura que deriva del mismo y obtener el máximo de satisfacción.

From its earliest manifestations on the street corners of nineteenth-century Buenos Aires to its ascendancy as a global cultural form, tango has continually exceeded the confines of the dance floor or the music hall. In Tango Lessons, scholars from Latin America and the United States explore tango's enduring vitality. The interdisciplinary group of contributors—including specialists in dance, music, anthropology, linguistics, literature, film, and fine art—take up a broad range of topics. Among these are the productive tensions between tradition and experimentation in tango nuevo, representations of tango in film and contemporary art, and the role of tango in the imagination of Jorge Luis Borges. Taken together, the essays show that tango provides a kaleidoscopic perspective on Argentina's social, cultural, and intellectual history from the late nineteenth to the early twenty-first centuries. Contributors. Esteban Buch, Oscar Conde, Antonio Gómez, Morgan James Luker, Carolyn Merritt, Marilyn G. Miller, Fernando Rosenberg, Alejandro Susti