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International Conference on Harmonisation.
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61
Guidance for industry Q1E evaluation of stability data
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2004
Description: 18 pages : digital, PDF file.
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62
Guidance for industry Q1A(R2) stability testing of new drug substances and products
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2003
Description: i, 22 pages : digital, PDF file.
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Guidance for industry addendum to E2C clinical safety data management : periodic safety update reports for marketed drugs
Published: U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, 2004
Description: 9 pages : digital, PDF file.
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Related Subjects
Drugs Testing
Clinical trials Reporting
Clinical pharmacology
Drug approval Government policy
Clinical trials Reporting Government policy
Drug stability
Drug development Government policy
Drugs Microbiology Testing
Pharmaceutical chemistry
Clinical trials
Document imaging systems
Drug adulteration Government policy
Drug approval
Drug development
Drugs Side effects Reporting
Genetic toxicology
Palpitation
Parenteral therapy
Pharmaceutical biotechnology
Pharmacopoeias Standards International cooperation
Solvents
Antineoplastic agents Evaluation
Biological products Evaluation
Biological products Testing
Biopharmaceutics
Biotechnology Research Standards International cooperation
Biotechnology Safety measures
Capsules (Pharmacy) Testing
Carcinogenicity testing
Children Diseases Chemotherapy
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