Development of specifications for biotechnology pharmaceutical products : Hyatt Regency, San Francisco CA, USA, May 2-3, 1996
著者
書誌事項
Development of specifications for biotechnology pharmaceutical products : Hyatt Regency, San Francisco CA, USA, May 2-3, 1996
（Developments in biological standardization, v. 91）
Karger, c1997
大学図書館所蔵 件 / 全1件
-
該当する所蔵館はありません
- すべての絞り込み条件を解除する
注記
"Proceedings of a symposium organized and sponsored by the PDA West Coast chaper and International Association of Biological Standardization (IABS)"
内容説明・目次
内容説明
This volume contains the proceedings of a two-day symposium on 'Development of Specifications for Biotechnology Pharmaceutical Products', held in May 1996. Speakers and panelists from industry and regulatory agencies discussed specifications and the degree to which they are appropriately applied during the various stages of drug development. Presentations evaluating raw material, in-process and final product specification development throughout the drug development timeline for biotechnology pharmaceutical products were given. Specifications for identity, purity and activity at various stages of drug development were also considered. Further contributions examined assay and process validations and their effects on specification setting, stressing that the quality of the validation directly effects the setting of a suitable specification. Finally, standards and reference materials, and their selection for in-house use and as the basis for setting future global standards were discussed. As a result, it was emphasized that the development of specifications evolves with the product through a continuum of improved processes and characterizations leading to superior product quality. Bringing together the world's leading experts in the field, this book will be a valuable reference for pharmaceutical development professionals involved in research, development and commercialization including members of quality control, quality assurance, regulatory affairs, process development, analytical development, validation and regulatory compliance groups.
目次
- Global perspective on specifications for biotechnology products: FDA perspective on specifications for biotechnology products - from IND to PLA
- global perspective on specifications for biotechnology products - perspective from Japan
- development of specifications for biotechnology products - perspectives from Europe
- specifications from a biotechnology industry perspective. Evolution of specifications through product development: appropriate specifications at the IND stage
- global regulatory considerations for unified assay specifications
- characterization and establishment of specifications for biopharmaceuticals. Environmental control: workshop summary. Specifications - what is necessary to start clinical trials?: workshop summary. Specifications within the manufacturing operation: material considerations
- in-process testing and limits
- the use of bioassays for the characterization and control of biological therapeutic products produced by biotechnology. In-process testing/limits: workshop summary. Reference standards/materials: workshop summary. Role of the pharmacopoeia and validation in specification development: the role of assay validation in specification development.
「Nielsen BookData」 より
