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

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

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

7. Drugs vs. public health

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

14. Report of the Committee on Adulterations and Sophistications of Drugs, Medicines, Chemicals, etc: presented to the American Medical Association at its third annual meeting, held in Cincinnati, May, 1850

20. Testing of retroviral vector-based human gene therapy products for replication competent retrovirus during product manufacture and patient follow-up