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Our Nun
Set in a rural farming community in western Pennsylvania, this novel gives fresh voice to the great tradition of the American pastoral. The classic idyll goes awry when young Boyd Robison and his friends find a body in the local churchyard, causing Boyd and his buddies to take a closer look at the odd characters-and sudden suspects-in their close-knit community. Dry, understated wit and Boyd's naive bravery turn this seemingly dark tale into a joyful and charming story about growing up in America's heartland.
Fundamentals of International Regulatory Affairs, Second Edition
Reference book of laws, standards and regulations applicable to healthcare product manufacture on the international market.
The Mother of All Arts
When Gene Logsdon realized that he experienced the same creative joy from farming as he did from writing, he suspected that agriculture itself was a form of art. Thus began his search for the origins of the artistic impulse in the agrarian lifestyle. The Mother of All Arts is the culmination of Logsdon’s journey, his account of friendships with farmers and artists driven by the urge to create. He chronicles his long relationship with Wendell Berry and discovers the playful humor of several new agrarian writers. He reveals insights gleaned from conversations with Andrew Wyeth and his family of artists. Through his association with musicians such as Willie Nelson and his involvement with Far...
The Communicator
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Legacy
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Development of Biopharmaceutical Drug-Device Products
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most...
