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11. 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
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. 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
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. 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
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. 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
Capsules
Congresses as Topic
International Cooperation
Tablets
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. 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
Congresses as Topic
International Cooperation
Tablets
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 10(R1) : polyacrylamide gel electrophoresis general chapter

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

17. 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
Sterilization
Congresses as Topic
International Cooperation
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, October 2017
Subject(s):
Documentation -- standards
Drug Approval
Congresses as Topic
European Union
International Cooperation
Pharmaceutical Preparations -- standards
Humans
Canada
Europe
Japan
Switzerland
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

20. Physician payment: current system and opportunities for reform

Publication:
Washington, D.C. : AARP Public Policy Institute, c2009
Subject(s):
Health Care Reform
Physicians
Prospective Payment System -- organization & administration
Reimbursement Mechanisms -- organization & administration
Medicare Part B -- economics
Patient-Centered Care
Primary Health Care -- economics
Humans
France
Germany
United Kingdom
Japan
United States