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Start Over Subjects Neoplasms -- drug therapy ✖Remove constraint Subjects: Neoplasms -- drug therapy Languages English ✖Remove constraint Languages: English

11. Considerations for the inclusion of adolescent patients in adult oncology clinical trials

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Clinical Trials as Topic -- ethics
Adolescent
Neoplasms -- drug therapy
Adult
Medical Oncology -- ethics
Patient Safety
Patient Selection
Pharmacokinetics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Enrichment strategies for clinical trials to support determination of effectiveness of human drugs and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
Subject(s):
Clinical Trials as Topic
Prognosis
Research Design
Biomarkers, Pharmacological
Biomarkers, Tumor
Captopril -- therapeutic use
Cardiovascular Diseases -- drug therapy
Clozapine -- therapeutic use
Cyclooxygenase 2 Inhibitors -- therapeutic use
Drugs, Investigational
Lung Diseases -- drug therapy
Medication Adherence
Neoplasms -- drug therapy
Patient Compliance
Patient Selection
Pharmacogenetics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Oncology pharmaceuticals: reproductive toxicity testing and labeling recommendations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Subject(s):
Antineoplastic Agents -- adverse effects
Mutagenicity Tests -- standards
Neoplasms -- drug therapy
Reproduction -- drug effects
Teratogens
Toxicity Tests -- standards
Contraception
Drug-Related Side Effects and Adverse Reactions
Fertility
Geriatrics
Pediatrics
Postmenopause
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. Oncology therapeutic radiopharmaceuticals: nonclinical studies and labeling recommendations

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Drug Evaluation, Preclinical -- standards
Neoplasms -- drug therapy
Radiopharmaceuticals -- pharmacology
Toxicity Tests
Carcinogenicity Tests
Drug Labeling
Lactation -- drug effects
Pharmacokinetics
Radiation Dosage
Animals
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. Placebos and blinding in randomized controlled cancer clinical trials for drug and biological products

Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):
Double-Blind Method
Neoplasms -- drug therapy
Placebos
Randomized Controlled Trials as Topic -- standards
Single-Blind Method
Antineoplastic Agents
Biological Products
Randomized Controlled Trials as Topic -- ethics
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.