MOLRECORD
Index · A–Z

Glossary

26 ITEMS

  • TERM
    503A
    The section of the US Food, Drug, and Cosmetic Act covering compounding by state-licensed pharmacies and physicians for individual patients.
    3 ENTRIES
  • TERM
    503B
    The section covering registered outsourcing facilities that compound in larger quantities under federal quality rules.
    1 ENTRY
  • TERM
    Bulks list
    The FDA's list of bulk drug substances that may be used in compounding when no monograph or approved-drug route applies.
    2 ENTRIES
  • TERM
    Category 2
    A holding category for nominated substances the FDA considers to raise significant safety concerns; placement discourages compounding with them.
    2 ENTRIES
  • TERM
    CDMO
    Contract development and manufacturing organisation, a company that makes drug substances for others.
    1 ENTRY
  • TERM
    Compounding
    Preparing a medicine for a specific patient or facility from ingredients rather than dispensing a manufactured, approved product.
    2 ENTRIES
  • TERM
    DOI
    Digital object identifier, a permanent reference for a published paper.
    1 ENTRY
  • TERM
    Endotoxin (LAL test)
    Bacterial contaminants that cause fever; the LAL test is the standard assay for them in injectable preparations.
    0 ENTRIES
  • TERM
    GHRH analogue
    A modified form of growth-hormone-releasing hormone that prompts the pituitary to release growth hormone.
    0 ENTRIES
  • TERM
    GIP
    Glucose-dependent insulinotropic polypeptide, a second gut hormone targeted by dual and triple agonists.
    2 ENTRIES
  • TERM
    GLP-1 receptor agonist
    A drug that activates the receptor for glucagon-like peptide-1, lowering blood glucose and appetite.
    6 ENTRIES
  • TERM
    HPLC
    High-performance liquid chromatography, the standard method for measuring a peptide's purity.
    0 ENTRIES
  • TERM
    Immunogenicity
    The tendency of a substance to provoke an immune response, including antibodies that can reduce a drug's later effectiveness.
    1 ENTRY
  • TERM
    Lyophilised
    Freeze-dried. Most research peptides are supplied as a lyophilised powder for stability.
    1 ENTRY
  • TERM
    Mass spectrometry
    A method that measures molecular mass, used to confirm a peptide's identity.
    0 ENTRIES
  • TERM
    Mitochondrial-derived peptide
    A short peptide encoded within mitochondrial DNA rather than the nuclear genome, such as MOTS-c.
    0 ENTRIES
  • TERM
    NCT number
    The identifier of a study registered on ClinicalTrials.gov, the US public trial registry.
    1 ENTRY
  • TERM
    PCAC
    The Pharmacy Compounding Advisory Committee, an FDA advisory panel whose votes are recommendations rather than decisions.
    2 ENTRIES
  • TERM
    Phase I
    First-in-human studies, usually small, designed to assess safety and how the body handles a compound.
    1 ENTRY
  • TERM
    Phase III
    Large confirmatory trials designed to establish efficacy and safety for a regulatory submission.
    2 ENTRIES
  • TERM
    Preclinical
    Evidence from laboratory and animal studies, before any testing in people.
    3 ENTRIES
  • TERM
    Randomised controlled trial
    A study that assigns participants at random to a treatment or a comparator; the standard for showing that a treatment causes an effect.
    2 ENTRIES
  • TERM
    Secretagogue
    A substance that causes another substance to be secreted; here, peptides that trigger growth-hormone release.
    0 ENTRIES
  • TERM
    Topline results
    A sponsor's first summary of a trial's main outcomes, usually by press release, before the full peer-reviewed paper.
    1 ENTRY
  • TERM
    Triple agonist
    A single molecule that activates three receptors; retatrutide targets GIP, GLP-1 and glucagon receptors.
    1 ENTRY
  • TERM
    WADA S0
    The World Anti-Doping Agency's category for non-approved substances, prohibited at all times in sport.
    0 ENTRIES