Transcription of Study Protocol – Stage 2 - PQRI
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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group Issued and Effective September, 2011 Study Protocol Stage 2 Experimental Protocol for Simulation Study of Blow-Fill-Seal (BFS) PODP Container Closure Systems PODP Issued and Effective Leachables and Extractables Working Group September, 2011 Experimental Protocol for Simulation Study , Stage 2 TABLE OF CONTENTS 24 25 26 27 28 29 30 31 32 33
PODP Issued and Effective Leachables and Extractables Working Group September, 2011 Experimental Protocol for Simulation Study, Stage 2 178 II. Purpose and Scope of Work (Study Protocol Stage 2)
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