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

Author:

Kretsinger Juliana,Frantz Neha,Hart Scott A.,Kelley Wayne P.,Kitchen Bob,Novick Shawn,Rellahan Barbara,Stranges Daniela,Stroop Corné J.M.,Yin Ping,Gastens Martin H.

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference7 articles.

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2. Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Procedures Chemical Substances,1999

3. Early development GMPs for small-molecule specifications: an industry perspective (part V);Zhang;Pharm Technol,2012

4. PCMO L01-setting specifications for biological investigational medicinal products;Krause;PDA J Pharm Sci Technol,2015

5. The Challenge of CMC Regulatory Compliance for Biopharmaceuticals;Geigert,2004

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