Книга Development of Biopharmaceutical Parenteral Dosage Forms
Код товару: 20090772
Формат
Мова книги
Видавництво
Рік видання
Опис книги details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process
describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization
considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance
elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity
shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends
reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications
and more!
Furnished with helpful references, tables, and drawings, this practical guide is indispensable
This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process.
Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms
Furnished with helpful references, tables, and drawings, this practical guide is indispensable
Характеристики
Видавництво
Кількість сторінок
264
Рік видання
2019
Мова
Англійська
Ілюстрації
Немає ілюстрацій
Тип
Паперова
Тип обкладинки
М'яка
Вага
500
ISBN
9780367400910
Формат
152x229 мм
Код
20090772
Відгуки
Виникли запитання?
0-800-335-425
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