Handbook of Biogeneric Therapeutic Proteins: Regulatory, - download pdf or read online

By Sarfaraz K. Niazi

ISBN-10: 0849329914

ISBN-13: 9780849329913

greater than 20 billion cash worthy of biopharmaceuticals are scheduled to head off-patent via 2006. Given the robust political impetus and the improvement of technological instruments which could resolution the questions regulatory gurus might bring up, it's inevitable that the FDA and EMEA will enable biogeneric or biosimilar items. in spite of the entire regulatory wrinkles but to be ironed out, usual or related organic items are quickly to turn into a reality.

Handbook of Biogeneric healing Proteins is the 1st booklet to check and learn the prestige of biotechnology, regulatory setting, production methodologies, checking out standards and highbrow estate matters. The e-book presents entire and thorough insurance of the regulatory and technological demanding situations of constructing commonly used healing proteins and the way to organize particular regulatory and production plans and guidelines. the writer comprises details on developing a producing process, securing regulatory approval, and constructing amenities to fabricate uncooked fabrics and get ready accomplished items. He additionally provides information about the Chemistry, production, and Controls (CMC) component of the FDA's New Drug software for organic items. briefly, the ebook offers every thing a producer would have to plan the advance of biogeneric items and entire the method of regulatory filing.

Waiting for the FDA to factor instructions is a mistake. The scramble to trap up may perhaps go away your organization manner at the back of within the online game. your company must start constructing and characterizing genetically converted cells now and to accomplish preliminary GMP creation runs via a CRO to prepare for the more moderen checking out the FDA may possibly impose. full of tables and figures that supply quickly entry to specific, well timed info, together with complete formula info on all FDA licensed organic product, this booklet incorporates a large diversity of source fabrics approximately providers, brands, and trying out amenities. those positive factors mixed with the author's hands-on, sensible procedure provide the side you need.

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Handbook of Biogeneric Therapeutic Proteins: Regulatory, Manufacturing, Testing, and Patent Issues by Sarfaraz K. Niazi

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