NLM Digital Collections

Search

Start Over Collections Health Policy and Services Research ✖Remove constraint Collections: Health Policy and Services Research Subjects Drug Contamination ✖Remove constraint Subjects: Drug Contamination

1. 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
Biological Products -- standards
Congresses as Topic
Drug Approval
Drug Contamination
International Cooperation
Quality Control
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

2. 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
Drug Contamination
Drug Labeling -- standards
International Cooperation
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
Subject(s):
Antineoplastic Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Antineoplastic Agents -- toxicity
Drug Approval
Drug Contamination
Research Design
Toxicity Tests
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

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

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

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

Publication:
Silver Spring, MD : Center for Biologics Evaluation and Research, January 2020
Subject(s):
Drug Contamination
Genetic Therapy
Genetic Vectors
Retroviridae
Virus Replication
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

9. 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

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2023
Subject(s):
Drug Contamination
Drug Industry
Drug-Related Side Effects and Adverse Reactions
Ethylene Glycols
Glycerol
Government Regulation
Propylene Glycol
Sorbitol
United States