Subjects: Chemistry, Pharmaceutical -- standards - Digital Collections - National Library of Medicine Search Results

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NLM Digital Collections

Start Over Subjects Chemistry, Pharmaceutical -- standards

1. Q3C--tables and list

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, [June 2017]
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Compounding -- standards
Solvents -- classification
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

2. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 5(R1) : disintegration test general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

3. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 9(R1) : tablet friability general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 8 (R1) : sterility test general chapter

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2017
Subject(s):: Chemistry, Pharmaceutical -- standards
Drug Approval
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Regulatory classification of pharmaceutical co-crystals

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Chemistry, Pharmaceutical -- classification
Chemistry, Pharmaceutical -- standards
Crystallization -- classification
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

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

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):: Chemistry, Pharmaceutical -- standards
Pharmaceutical Preparations -- standards
Quality Control
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration