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Start Over Subjects International Cooperation ✖Remove constraint Subjects: International Cooperation Genre Technical Report ✖Remove constraint Genre: Technical Report

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. E18 genomic sampling and management of genomic data

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):
Data Collection -- standards
Genomics -- standards
Specimen Handling -- standards
Confidentiality
Genetic Testing
Genotyping Techniques
Information Management -- standards
Informed Consent
International Cooperation
Privacy
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. E11(R1) addendum: clinical investigation of medicinal products in the pediatric population

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, April 2018
Subject(s):
Clinical Trials as Topic -- ethics
Drug Compounding -- standards
Pediatrics
Pharmaceutical Preparations
Child
Excipients
Infant
Infant, Newborn
International Cooperation
Models, Theoretical
Pharmaceutical Preparations -- administration & dosage
Taste
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. 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.

7. E14 clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs--questions and answers (R3)

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, June 2017
Subject(s):
Arrhythmias, Cardiac -- chemically induced
Arrhythmias, Cardiac -- diagnosis
Cardiac Electrophysiology -- methods
Cardiac Electrophysiology -- standards
Drug Approval
Electrocardiography -- standards
Long QT Syndrome -- chemically induced
Cardiotoxins
Clinical Trials as Topic
Congresses as Topic
Diagnosis, Computer-Assisted
Drug-Related Side Effects and Adverse Reactions
International Cooperation
Pharmaceutical Preparations -- administration & dosage
Reference Standards
Research Design
Sex Factors
Humans
Europe
Japan
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

10. Q4B evaluation and recommendation of pharmacopoeial texts for use in the ICH regions: annex 1(R1) : residue on ignition/sulphated ash general chapter

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