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- W650307302 abstract "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." @default.
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- W650307302 date "1997-01-01" @default.
- W650307302 modified "2023-09-23" @default.
- W650307302 title "Development of specifications for biotechnology pharmaceutical products : Hyatt Regency, San Francisco CA, USA, May 2-3, 1996" @default.
- W650307302 hasPublicationYear "1997" @default.
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