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Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
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Development of Biopharmaceutical Parenteral Dosage Forms (Paperback)
Loot Price: R2,041
Discovery Miles 20 410
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Development of Biopharmaceutical Parenteral Dosage Forms (Paperback)
Expected to ship within 12 - 19 working days
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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 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
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