A number that tells you how likely a study's result would be if the treatment had no real effect. A p-value below 0.05 is conventionally considered 'statistically significant' — meaning there's less than a 5% chance the result is due to random chance alone. But a low p-value doesn't tell you how large or clinically meaningful the effect is.
See also: Statistical significance, Effect size
The chemical link that connects one amino acid to the next in a peptide chain. Peptide bonds form through a condensation reaction and are broken by digestive enzymes — which is why most peptides can't be taken orally.
See also: Amino acid, Sequence
Read more →The FDA's classification system for peptides in the context of compounding. Category 1 peptides can be compounded by pharmacies. Category 2 peptides are under evaluation. Category 3 peptides cannot be compounded due to safety or other concerns. Reclassification between categories is an ongoing process that directly affects patient access.
Also known as: FDA peptide categories, Category 1, Category 2, Category 3
See also: FDA, Compounding pharmacy, Bulk drug substance
Read more →A hormone made of amino acid chains that carries signals through the bloodstream to distant organs. Insulin, growth hormone, and GLP-1 are peptide hormones. Unlike steroid hormones, peptide hormones cannot cross cell membranes and must bind to receptors on the cell surface.
See also: Receptor, Endogenous, Neuropeptide
Read more →What a drug does to the body — its biological effects, mechanism of action, and the relationship between concentration and response. In simpler terms: pharmacokinetics asks 'how does the body handle this drug?' while pharmacodynamics asks 'how does this drug affect the body?'
Also known as: PD
See also: Pharmacokinetics, Mechanism of action, Dose-response
How the body absorbs, distributes, metabolizes, and eliminates a drug over time. Pharmacokinetic studies tell us how quickly a peptide reaches peak levels, how long it stays active, and how the body clears it — all of which determine dosing schedules.
Also known as: PK
See also: Pharmacodynamics, Half-life, Bioavailability
The first stage of testing a new drug in humans, focused primarily on safety. Phase I trials typically enroll 20-80 healthy volunteers to determine safe dosage ranges, identify side effects, and study how the body processes the drug.
See also: Phase II trial, Phase III trial, Investigational new drug
The second stage of human testing, focused on whether a drug actually works for its intended condition. Phase II trials typically enroll 100-300 patients and test different doses to find the most effective one. Many promising drugs fail at this stage.
See also: Phase I trial, Phase III trial
Large-scale trials (typically 1,000-5,000+ patients) designed to confirm a drug's effectiveness and monitor side effects in a broader population. Phase III trials are the final step before seeking FDA approval. Semaglutide's STEP and SUSTAIN programs were Phase III trials.
See also: Phase II trial, New drug application, Randomized controlled trial
An inactive treatment — like a saline injection or sugar pill — given to a control group in a clinical trial. Comparing outcomes between the treatment group and the placebo group reveals how much of the observed effect is actually caused by the drug, versus the patient's belief that they are receiving treatment.
See also: Double-blind, Randomized controlled trial
The single most important result a clinical trial is designed to measure. The entire study is powered (sized) to detect a meaningful difference in this outcome. Results for the primary outcome carry the most weight when evaluating whether a treatment works.
See also: Endpoint, Statistical significance
The percentage of a peptide product that is the intended molecule, as opposed to contaminants, degradation products, or synthesis byproducts. Measured by HPLC. Research-grade peptides typically have 95-99%+ purity. Higher purity reduces the risk of unwanted reactions.
See also: HPLC, Certificate of analysis