Streamlining ICH Q6B Analytical Testing of Biotherapeutics
نویسندگان
چکیده
منابع مشابه
A Stress Testing Benchmarking Study
portant part of the drug development process, and the pharmaceutical industry’s considerable interest in this topic has led to the publication of an article by the Pharmaceutical Research and Manufacturer’s of America (PhRMA) in Pharmaceutical Technology (1). Although the concept of stress testing is not new to the pharmaceutical industry, the procedure was not clearly defined until the Interna...
متن کاملManaging the Analytical Lifecycle for Biotechnology Products
Biotechnology pipelines have demonstrated significant growth over the past decade, with many therapeutic candidates evolving in a single class of protein molecules: the monoclonal antibodies (MAbs). To develop such therapeutic candidates, a scalable drug development process must leverage in-house and industry-wide knowledge so biotechnology companies can address the economic and medical needs o...
متن کاملStep-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry
Method validation is an important requirement for any package of information submitted to international regulatory agencies in support of new product marketing or clinical trials applications. Analytical methods should be validated, including methods published in the relevant pharmacopoeia or other recognized standard references. The suitability of all test methods used should always be verifie...
متن کاملRecent Advances in Biotherapeutics Drug Discovery and Development
Biotherapeutics drugs, such as antibodies, Fc-like fusion proteins, and therapeutic replacement enzymes, constitute the most rapidly growing drug class, and have become a major clinical success of human therapeutics over the past decade. These therapeutics of large-molecule have revolutionized the treatment of a variety of diseases in areas such as oncology, inflammatory and autoimmune diseases...
متن کاملShape Optimization of an abrupt contraction using numerical streamlining
This research was conducted to find a reliable technique to shape an abrupt contraction for minimizing the energy loss. The method may find broader applications in design of variety of transitional cross-sections in hydraulic structures. The streamlines in a 2-D contraction were calculated through solving the potential flow equations in rectangular and curvilinear coordinates. The natural cubic...
متن کامل