The business case for quality by design is drawing scrutiny as the cost of QbD-related process design experiments mounts and regulatory incentives languish. FDA officials encourage industry to concentrate on the business benefits of QbD. CMC pilots raised questions about cost effectiveness. McKinsey consultant argues that the QbD business case is strong but little understood. One key is to utilize resources more, as other industries do. Another is to reduce the cost of drugs by speeding up process development like IBM and auto makers did. If it's quick enough, it can wait until after clinical proof of concept. QbD offers $20 billion to $30 billion of additional profits, mainly by reducing the cost of goods sold, particularly through cycle time reduction, and also by improving the productivity of technology development. But perhaps the most important advance would involve basic research such as NIPTE is planning to do that would establish first principles of pharmaceutical engineering, obviating the need for costly and time-consuming empirical design studies.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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