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  1. NLM Digital Collections - Hospital literature index (Volume 48) 
    resource.nlm.nih.gov/7807587X35
    ... Mar-Apr;23(2):81 -2 Creating a clinical development plan for acute care nurses. Rodriguez L. J Contin ... 1992 Feb;17(l):37-51 Creating a clinical development plan for acute care nurses. Rodriguez L. J Contin ...
  2. NLM Digital Collections - S11 nonclinical safety testing in support of development of pediatric pharmaceuticals 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2021
    resource.nlm.nih.gov/9918350987106676
    ... compared to adults. An understanding of the overall clinical development plan is needed to design an appropriate, efficient nonclinical ... 2) A. Clinical Context (2.1) The pediatric clinical development plan for a pharmaceutical is discussed in the ICH ...
  3. NLM Digital Collections - Vulvovaginal candidiasis : developing drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
    resource.nlm.nih.gov/101760287
    ... Sponsors are encouraged to begin discussing their pediatric clinical development plan as early as is feasible because pediatric studies ... 3 clinical trials may fulfill the required pediatric clinical development plans. In general, safe and effective treatments are available ...
  4. NLM Digital Collections - Complicated urinary tract infections : developing drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2018
    resource.nlm.nih.gov/101734286
    ... treatment of uncomplicated urinary tract infections should discuss clinical development plans with the FDA. This guidance does not contain ... are encouraged to begin discussions about their pediatric clinical development plan as early as is feasible because pediatric studies ...
  5. NLM Digital Collections - Migraine : developing drugs for acute treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
    resource.nlm.nih.gov/101734065
    ... are encouraged to begin discussions about their pediatric clinical development plan early in development because sponsors are required to ... are encouraged to begin discussions about their pediatric clinical development plan early in development because they are required to ...
  6. NLM Digital Collections - Bacterial vaginosis : developing drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, August 2019
    resource.nlm.nih.gov/101760284
    ... FDA encourages sponsors to begin discussions about pediatric clinical development plans as early as is feasible because pediatric studies ... may be capable of fulfilling the required pediatric clinical development plans. 8 Nugent RP, MA Krohn, and SL Hillier, ...
  7. Interventions - Mental health of adults in contact with the criminal justice system - NCBI Bookshelf 
    https://www.ncbi.nlm.nih.gov/books/NBK533122
    ... who had experienced ACI. Identification may assist with clinical decision making, development of management plans and the assessment of risk. This may, in ...
  8. NLM Digital Collections - Chronic hepatitis C virus infection : developing direct-acting antiviral drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, November 2017
    resource.nlm.nih.gov/101719919
    ... to begin discussions about their pediatric formulations and clinical development plans early in development because pediatric assessments are required ...
  9. NLM Digital Collections - Cytomegalovirus in transplantation : developing drugs to treat or prevent disease 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2020
    resource.nlm.nih.gov/9918231202806676
    ... to begin discussions about their pediatric formulation and clinical development plan early in development because pediatric clinical trials are a required part of the overall ...
  10. NLM Digital Collections - Premenopausal women with breast cancer : developing drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, June 2021
    resource.nlm.nih.gov/9918350981806676
    ... patients should be collected as part of the clinical development plan and analyzed overall and by stratification (if applicable) based on menopausal status at study entry. As warranted under applicable law ... effects. 7 • Clinical studies evaluating drugs in premenopausal ...
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