Remaining on the cutting-edge of this rapidly evolving field, this unequaled resource has expanded more than 70% of its original entries to review ammendments to regulatory requirements and recently developed statistical methods impacting the drug review/approval process and biopharmaceutical research and development. Alerts specialists to current standards and best
practices in clinical, laboratory, manufacturing, and
statistical design, investigation, and analysis.
Chow has done an excellent job of collecting articles from the leading researchers in the pharmaceutical and biologics industry including FDA employees. The terms are specialized but important to