Subjects: Clinical Trials as Topic / Copyright: Public domain - Digital Collections - National Library of Medicine Search Results

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1. An address delivered before the Rhode-Island Homoeopathic Society

Author(s):: Okie, A. Howard (Abraham Howard)
Publication:: Providence : Whitney, 1850
Subject(s):: Homeopathy
Clinical Trials as Topic

2. Allergic rhinitis: developing drug products for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2018
Subject(s):: Clinical Trials as Topic
Drug Evaluation
Rhinitis, Allergic -- drug therapy
Adrenal Cortex Hormones -- therapeutic use
Adult
Child
Drug Combinations
Research Design
Single-Blind Method
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

3. Anthrax: developing drugs for prophylaxis of inhalational anthrax

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
Subject(s):: Anthrax -- drug therapy
Anthrax -- prevention & control
Antibiotic Prophylaxis
Clinical Trials as Topic
Drug Evaluation, Preclinical -- standards
Drugs, Investigational -- therapeutic use
Inhalation Exposure
Adult
Child
Endpoint Determination
Microbial Sensitivity Tests -- standards
Pediatrics
Product Surveillance, Postmarketing -- standards
Research Design
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

4. Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2017
Subject(s):: Anti-Bacterial Agents -- therapeutic use
Bacterial Infections -- drug therapy
Drug Approval
Drug Resistance, Bacterial
Investigational New Drug Application
Clinical Trials as Topic
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

5. Appropriate use of voluntary consensus standards in premarket submissions for medical devices: guidance for industry and Food and Drug Administration staff

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 14, 2018
Subject(s):: Clinical Trials as Topic
Consensus
Device Approval
Equipment and Supplies -- standards
Voluntary Programs
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
United States.

6. Assessing COVID-19-related symptoms in outpatient adult and adolescent subjects in clinical trials of drugs and biological products for COVID-19 prevention or treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, September 2020
Subject(s):: Clinical Trials as Topic
COVID-19 -- drug therapy
COVID-19 -- prevention & control
Outpatients
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

7. Bacterial vaginosis: developing drugs for treatment

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
Subject(s):: Clinical Trials as Topic
Drug Development
Vaginosis, Bacterial -- drug therapy
Pharmacokinetics
Research Design
Safety
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

8. Bioavailability studies submitted in NDAs or INDs: general considerations

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, April 2022
Subject(s):: Biological Availability
Clinical Trials as Topic
Drug Approval
Drug Evaluation
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration

9. Cancer clinical trial eligibility criteria: available therapy in non-curative settings

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, July 2022
Subject(s):: Clinical Trials as Topic
Government Regulation
Neoplasms -- drug therapy
United States
United States. Food and Drug Administration

10. Cancer clinical trial eligibility criteria: brain metastases

Publication:: Silver Spring, MD : Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Brain Neoplasms
Clinical Trials as Topic
Eligibility Determination
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

11. Cancer clinical trial eligibility criteria: minimum age considerations for inclusion of pediatric patients : guidance for industry and IRBs

Publication:: Silver Spring, MD : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Eligibility Determination
Neoplasms
Pediatrics
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

12. Cancer clinical trial eligibility criteria: patients with HIV, hepatitis B Virus, or hepatitis C Virus Infections

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Hepatitis B
Hepatitis C
HIV
Neoplasms
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

13. Cancer clinical trial eligibility criteria: patients with organ dysfunction or prior or concurrent malignancies

Publication:: [Silver Spring, MD] : United States Food and Drug Administration, Oncology Center of Excellence, July 2020
Subject(s):: Clinical Trials as Topic
Eligibility Determination
Heart Failure
Liver Failure
Neoplasms
Renal Insufficiency
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

14. Chronic hepatitis C virus infection: developing direct-acting antiviral drugs for treatment

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 -- standards
Drugs, Investigational -- therapeutic use
Hepatitis C, Chronic -- drug therapy
Antiviral Agents -- pharmacokinetics
Drugs, Investigational -- pharmacokinetics
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

15. Chronic obstructive pulmonary disease: use of the St. George's Respiratory Questionnaire as a PRO assessment tool

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
Subject(s):: Patient Outcome Assessment
Patient Reported Outcome Measures
Pulmonary Disease, Chronic Obstructive -- therapy
Surveys and Questionnaires
Clinical Trials as Topic
Outcome Assessment (Health Care)
Self-Assessment
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

16. Civil money penalties relating to the ClinicalTrials.gov data bank: guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff

Publication:: Silver Spring, MD : United States Food and Drug Administration, Office of Good Clinical Practice. August 2020
Subject(s):: Clinical Trials as Topic
Databases as Topic
Data Management -- legislation & jurisprudence
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

17. Clarification of orphan designation of drugs and biologics for pediatric subpopulations of common diseases

Publication:: Silver Spring, MD : Office of Orphan Products Development, Food and Drug Administration, July 2018
Subject(s):: Drug Approval
Orphan Drug Production
Pediatrics
Adolescent
Biological Products
Child
Clinical Trials as Topic
Colitis, Ulcerative -- drug therapy
HIV Infections -- drug therapy
Infant
Prevalence
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

18. Clinical drug interaction studies: cytochrome P450 enzyme- and transporter-mediated drug interactions

Publication:: Silver Spring, MD : Center for Drug Evaluation and Research, January 2020
Subject(s):: Drug Interactions
Clinical Trials as Topic
Cytochrome P-450 Enzyme System
Drugs, Investigational
Membrane Transport Proteins
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.

19. Clinical trials supported by the National Eye Institute: evaluating new approaches to the treatment of eye and vision disorders

Publication:: [Bethesda, Md. : National Eye Institute, 19--]
Subject(s):: Eye Diseases -- therapy
Vision Disorders -- therapy
Clinical Trials as Topic
Eye -- blood supply

20. 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
Drug Labeling -- standards
Endpoint Determination -- standards
Research Design -- standards
Humans
United States
United States. Department of Health and Human Services.
United States. Food and Drug Administration.