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1. Q11 development and manufacture of drug substances (chemical entities and biotechnological/biological entities): questions and answers

2. Q7 good manufacturing practice guidance for active pharmaceutical ingredients: questions and answers

3. S9 nonclinical evaluation for anticancer pharmaceuticals: questions and answers

5. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 3(R1) : test for particulate contamination : subvisible particles general chapter

7. Testing of glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, sorbitol solution, and other high-risk drug components for diethylene glycol and ethylene glycol: guidance for industry