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32. Duchenne muscular dystrophy and related dystrophinopathies: developing drugs for treatment


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


36. E6(R2) good clinical practice: integrated addendum to ICH E6(R1)


37. M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk


39. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool


40. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation