共 50 条
- [21] Relationships among product characterization, process validation and preclinical/clinical studies for well-characterized products CHARACTERIZATION OF BIOTECHNOLOGY PHARMACEUTICAL PRODUCTS, 1998, 96 : 173 - 175
- [22] Changes in biologics regulations: Impact on development and validation of manufacturing processes for well-characterized products. ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 1997, 213 : 273 - BIOT
- [23] Well-characterized biologicals: Trends and views - Compounds can provide framework for research into biological products GENETIC ENGINEERING NEWS, 2000, 20 (17): : 21 - +
- [29] Establishment of criteria for determining comparability of "well-characterized" proteins CHARACTERIZATION OF BIOTECHNOLOGY PHARMACEUTICAL PRODUCTS, 1998, 96 : 79 - 81