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  2. Chloramphenicol - Wikipedia

    en.wikipedia.org/wiki/Chloramphenicol

    Chloramphenicol may cause bone marrow suppression during treatment; this is a direct toxic effect of the drug on human mitochondria. [23] This effect manifests first as a fall in hemoglobin levels, which occurs quite predictably once a cumulative dose of 20 g has been given. The anaemia is fully reversible once the drug is stopped and does not ...

  3. Amphenicol - Wikipedia

    en.wikipedia.org/wiki/Amphenicol

    Examples of amphenicols include chloramphenicol, thiamphenicol, azidamfenicol, and florfenicol. The first-in-class compound was chloramphenicol, introduced in 1949. Chloramphenicol was initially discovered as a natural product and isolated from the soil bacteria Streptomyces venezuelae; [2] however, all amphenicols are now made by chemical ...

  4. Investigational New Drug - Wikipedia

    en.wikipedia.org/wiki/Investigational_new_drug

    The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

  5. FDA approves opioid-free pain medication with 'no sign of ...

    www.aol.com/news/fda-approves-opioid-free-pain...

    In clinical trials, the non-opioid medication received high patient satisfaction ratings, with 83% reporting "good" to "excellent" pain relief in real-world applications, Cheng noted.

  6. Drug of last resort - Wikipedia

    en.wikipedia.org/wiki/Drug_of_last_resort

    With regard to antibiotics, antivirals, and other agents indicated for treatment of infectious pathological disease, drugs of last resort are commonly withheld from administration until after the trial and failure of more commonly used treatment options to prevent the development of drug resistance.

  7. Priority review - Wikipedia

    en.wikipedia.org/wiki/Priority_review

    The pediatric voucher program includes changes to the voucher program. First, the pediatric treatment developer can ask the FDA in advance for an indication of whether the disease qualifies as a rare, pediatric disease. [citation needed] The awardee must market the drug within 365 days of approval, or the voucher may be revoked.

  8. Expanded access - Wikipedia

    en.wikipedia.org/wiki/Expanded_access

    Expanded access or compassionate use is the use of an unapproved drug or medical device under special forms of investigational new drug applications (IND) or IDE application for devices, outside of a clinical trial, by people with serious or life-threatening conditions who do not meet the enrollment criteria for the clinical trial in progress ...

  9. Gray baby syndrome - Wikipedia

    en.wikipedia.org/wiki/Gray_baby_syndrome

    Since the syndrome is due to the accumulation of chloramphenicol, the signs and symptoms are dose related. [10] According to Kasten's review published in the Mayo Clinic Proceedings, a serum concentration of more than 50 μg/mL is a warning sign, [10] while Hammett-Stabler and John states that the common therapeutics peak level is 10-20 μg/mL and is expected to achieve after 0.5-1.5 hours of ...