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236 results
  1. NLM Digital Collections - Advanced prostate cancer : developing gonadotropin-releasing hormone analogues 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, May 2022
    resource.nlm.nih.gov/9918470188606676
    ... the use of a standardized approach to trial design. III. DEVELOPMENT PROGRAM A. Drug Product Development GnRH analogues typically contain a synthetic peptide ...
  2. NLM Digital Collections - M7(R2) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, July 2023
    resource.nlm.nih.gov/9918663780806676
    ... stability studies. If it is anticipated that formulation development and packaging design options are unable to control mutagenic degradation product levels to less than the acceptable limit and ...
  3. NLM Digital Collections - M7(R1) assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to ... 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, March 2018
    resource.nlm.nih.gov/101734078
    ... application. It is also recognized that commercial formulation design occurs later in clinical development and therefore efforts associated with drug product degradation products will be limited in the earlier ...
  4. NLM Digital Collections - Management of suspected bacterial lower urinary tract infection in adult women : a national ... 
    Publication: Edinburgh, Scotland : Scottish Intercollegiate Guidelines Network (SIGN), September 2020
    resource.nlm.nih.gov/101772275
    ... prescription of antimicrobials was identified to support the development of recommendations. 3.2.5 Non-pharmacological treatment A single RCT was identified which investigated the herbal product BNO 1045 (Canephron®). BNO 1045 administered for seven ...
  5. NLM Digital Collections - Research, Feb. 18-20, 1988 
    https://resource.nlm.nih.gov/101083016X7
    ... or is it too comfortably wedded to domestic products? Why must drug companies ... of drug development must be addressed. There is still a leadership ...
  6. NLM Digital Collections - The Health Consequences of Smoking: The Changing Cigarette 
    Publication: United States. Public Health Service. Office of the Surgeon General, 1981
    resource.nlm.nih.gov/101584932X305
    ... tar yield and tobacco weight, 209-210, 212 development of optimum tar to ni- cotine ratios, 184-185 effect of butt and overwrap lengths on tar and nicotine yields, 211 effect of product design on smoke composition, 49-50 federal regulation of, ...
  7. NLM Digital Collections - Duchenne muscular dystrophy and related dystrophinopathies : developing drugs for treatment 
    Publication: Silver Spring, MD : Center for Drug Evaluation and Research, February 2018
    resource.nlm.nih.gov/101734048
    ... encouraged to consult with the Division of Neurology Products early in clinical ... population. The design of studies in juvenile animals 18 and timing ...
  8. NLM Digital Collections - Presidential Commission on the HIV Epidemic, hearing on Research, part 3, transcript 
    Publication: Produced: 20 February 1988
    resource.nlm.nih.gov/101763264X108
    ... or is it too comfortably wedded to domestic products? Why must drug companies ... of drug development must be addressed. There is still a leadership ...
  9. NLM Digital Collections - Briefing Book, 1989-1990 
    https://resource.nlm.nih.gov/101083016X51
    ... to a Request for Proposals soliciting research on development of condoms from materials other than latex rubber. It is anticipated that projects dealing both with the design of new condoms and clinical testing of new products will be initiated. 47 NATIONAL EYE INSTITUTE Of ...
  10. NLM Digital Collections - Cumulative index of hospital literature (1975-1977) 
    resource.nlm.nih.gov/60120460RX7
    ... techniques—an aid to better med- ical equipment design. A.R.Eames. Eng Med (Engl) 5: 31-4 Ap 76 (ed p.30) Research and development for better medical care, (ed) J. Brown. Ann Biomed Eng 4: 109-10 Je 76 Safety standards for medical electronic products: UL 544. E.A.Greene. Purchasing Admin 1: ...
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