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  1. Sitosterolemia - GeneReviews® - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK131810
    ... to optimize outcome. Pregnancy management: There are no adequate and well-controlled studies of ezetimibe in pregnant women; ezetimibe can be ... pregnancy have not been established. There are no adequate and well-controlled studies of ezetimibe in pregnant women; ezetimibe can be ...
  2. Findings - Enzyme-Replacement Therapies for Lysosomal Storage Diseases - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK117223
    ... efficacy of a compound must be established through adequate and well-controlled studies. Due to the massive financial investment required to ...
  3. NLM Digital Collections - Pediatric information incorporated into human prescription drug and biological product ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2019
    resource.nlm.nih.gov/101760024
    ... drug is approved for pediatric use based on adequate and well-controlled studies in adults (i.e., extrapolation of effectiveness) with ... for this indication is supported by evidence from adequate and well-controlled studies in adults with additional pharmacokinetic and safety data ...
  4. NLM Digital Collections - Briefing Book, 1989-1990 
    https://resource.nlm.nih.gov/101083016X51
    ... drug in question is effective. An NDA requires adequate, well-controlled studies. The more widespread the intended use of the ... hundred patients satishied the agency’s requirement for an adequate, well-controlled study. No Phase 3 studies were re- quired. Toxicologic ...
  5. NLM Digital Collections - Anthrax : developing drugs for prophylaxis of inhalational anthrax 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2018
    resource.nlm.nih.gov/101734212
    ... the investigational drug to be studied in the adequate and well- controlled animal studies should be based on an understanding of the ... antibacterial drugs, the duration of administration in the adequate and well-controlled animal studies has been approximately 30 days; this has allowed ...
  6. NLM Digital Collections - Smallpox (variola virus) infection : developing drugs for treatment or prevention 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2019
    resource.nlm.nih.gov/101760558
    ... the animal models and the design of the adequate and well- controlled efficacy studies before initiating a study. During the December 14– ... 2) orthopoxvirus animal models proposed for use in adequate and well-controlled efficacy studies should be well-characterized and generate reproducible results ...
  7. NLM Digital Collections - Medication for the treatment of alcohol use disorder : a brief guide 
    Publication: Rockville, MD : U.S. Department of Health and Human Services Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment, Division of Pharmacologic Therapies, 2015
    resource.nlm.nih.gov/101672700
    ... effect on the fetus and there are no adequate, well-controlled studies in humans, but potential benefits may warrant use ...
  8. NLM Digital Collections - Technology assessment. Vaccine development : capabilities and challenges for addressing ... 
    Publication: Washington, DC : United States Government Accountability Office, November 2021
    resource.nlm.nih.gov/9918383084506676
    ... effectiveness is generally based on the results of adequate and well controlled studies evaluating a clinical disease endpoint (efficacy studies) or ... effectiveness is generally based on the results of adequate and well controlled studies evaluating a clinical disease endpoint (efficacy studies) or ...
  9. NLM Digital Collections - M4E(R2) : the CTD--efficacy 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2017
    resource.nlm.nih.gov/101713111
    ... should be identified, and reasons that any apparently adequate and well-controlled studies are not considered relevant should be provided. Prematurely ...
  10. Summary and Implications - Skin Substitutes for Treating Chronic Wounds - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK554210
    ... the adequacy of these studies and whether such studies would qualify as adequate and well-controlled clinical trials under any HHS regulatory framework. Evidence ...
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