Expectations for Phase-Appropriate Drug Substance and Drug Product Specifications for Early-Stage Protein Therapeutics

Title
Expectations for Phase-Appropriate Drug Substance and Drug Product Specifications for Early-Stage Protein Therapeutics
Authors
Keywords
antibody drug(s), monoclonal antibody(s), antibody drug conjugate(s) (ADC), physicochemical properties, drug-like property(s), protein aggregation, analytical chemistry, degradation product(s)
Journal
JOURNAL OF PHARMACEUTICAL SCIENCES
Volume -, Issue -, Pages -
Publisher
Elsevier BV
Online
2018-12-07
DOI
10.1016/j.xphs.2018.11.042

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