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Start Over Subjects Drug Evaluation, Preclinical ✖Remove constraint Subjects: Drug Evaluation, Preclinical Genre Guideline ✖Remove constraint Genre: Guideline

1. 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.

2. Microdose radiopharmaceutical diagnostic drugs: nonclinical study recommendations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2018
Subject(s):
Drug Evaluation, Preclinical
Radiopharmaceuticals -- administration & dosage
Radiopharmaceuticals -- pharmacokinetics
Diagnostic Imaging
Diagnostic Uses of Chemicals
Radiopharmaceuticals -- toxicity
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Recurrent herpes labialis: developing drugs for treatment and prevention

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Antiviral Agents -- therapeutic use
Clinical Trials as Topic
Drug Evaluation, Preclinical
Drugs, Investigational -- therapeutic use
Herpes Labialis -- drug therapy
Herpes Labialis -- prevention & control
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. General principles for evaluating the abuse deterrence of generic solid oral opioid drug products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
Subject(s):
Abuse-Deterrent Formulations -- standards
Analgesics, Opioid -- administration & dosage
Drugs, Generic
Investigational New Drug Application
Administration, Oral
Administration, Inhalation
Clinical Trials as Topic
Drug Evaluation, Preclinical
Injections
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.