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1. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 4A(R1) : microbiological examination of nonsterile products : microbial enumeration tests general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2010

Subject(s):

Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
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 4B(R1) : microbiological examination of nonsterile products : tests for specified microorganisms general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Drug Approval
Microbiological Techniques -- standards
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 4C(R1) : microbiological examination of nonsterile products : acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use general chapter

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, September 2017

Subject(s):

Drug Approval
Microbiological Techniques -- standards
Pharmacopoeias as Topic -- standards
Europe
Japan
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

4. Complicated intra-abdominal infections: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, May 2018

Subject(s):

Anti-Bacterial Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation -- standards
Drugs, Investigational -- pharmacokinetics
Intraabdominal Infections -- drug therapy
Microbiological Techniques -- standards
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

5. Complicated urinary tract infections: developing drugs for treatment

Publication:

Silver Spring, MD : Center for Drug Evaluation and Research, June 2018

Subject(s):

Anti-Bacterial Agents -- therapeutic use
Anti-Infective Agents, Urinary -- therapeutic use
Clinical Trials as Topic -- standards
Drug Evaluation
Microbiological Techniques -- standards
Urinary Tract Infections -- drug therapy
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration