Medicines and drug development
What Is a Peptide? Structure, Function, and Medicines
Peptides are short amino-acid chains with diverse biological roles. Learn how peptide medicines work, why delivery is difficult, and how to assess claims.
Health & Evidence Library
Medicines and drug development
How medicines are studied, approved, monitored, compared, deprescribed, and used within individualized benefit-risk decisions.
32 guides · Page 1 of 1
Medicines and drug development
Why Preclinical Breakthroughs Often Do Not Translate
How study design, biological relevance, reporting, replication, and incentives determine whether preclinical findings survive translation.
Medicines and drug development
Why Peptide Purity and Immunogenicity Matter
Why a peptide purity percentage cannot establish identity, consistency, sterility, potency, stability, or immune safety.
Medicines and drug development
When Adult Drug Evidence Can Support Pediatric Development
How ICH E11A uses disease, pharmacology, response, dosing, formulation, and safety evidence to plan pediatric extrapolation.
Medicines and drug development
SURMOUNT-1: How to Read a Weight-Loss Trial
SURMOUNT-1 reported large average weight reductions with tirzepatide. Learn how population, estimands, missing data, harms, and follow-up shape the result.
Medicines and drug development
Retatrutide Phase 2, Phase 3, and Approval
What retatrutide's phase 2 trial established, what 2026 phase 3 topline results add, and why neither a headline nor one trial is FDA approval.
Medicines and drug development
Research Peptides Online: Regulation and Evidence
What FDA approval, research-only labeling, and the 503A compounding process mean for BPC-157, TB-500, and other online peptides in July 2026.
Medicines and drug development
How GalNAc siRNA Medicines Silence Liver Genes
GalNAc directs siRNA to liver cells, where RNA interference lowers a chosen messenger RNA. Learn the mechanism, approved examples, and evidence limits.
Medicines and drug development
How Drug Programs Build an Integrated QT Prolongation Risk Assessment
How ion-channel studies, in vivo data, standardized ECGs, and concentration-QTc models combine to assess a medicine's QT liability.
Medicines and drug development
How Biologic Comparability Separates a Manufacturing Change From a Clinical Change
A risk-based guide to comparing biologics before and after a process change through quality, function, stability, and targeted bridging evidence.
Medicines and drug development
Generic vs. Brand-Name Drugs: What Is Different?
How FDA-approved generics match brand drugs, what bioequivalence means, and when inactive ingredients, formulation, or monitoring matter.
Medicines and drug development
Clinical Trial Phases Explained: What Each Can Prove
Clinical trial phases explained by question, participants, endpoints, controls, uncertainty, approval status, and postmarket evidence.
Medicines and drug development
Choosing a First-in-Human Starting Dose Without Treating One Formula as the Answer
A decision framework for selecting a first-in-human dose from toxicology, pharmacology, human predictions, uncertainty, and trial controls.
Medicines and drug development
Why Removing a Peptide From the FDA's Safety-Risk List Is Not the Same as Approving It
Removing a peptide from the FDA's Category 2 safety-risk list in 2026 is not approval, not Category 1, and not permission to compound
Medicines and drug development
When the Factory Is the Pharmacy: How CMC and GMP Decide If a Cell or Gene Therapy Reaches a Patient
For cell and gene therapies, manufacturing quality (CMC and GMP), not the biology, is usually the step that decides whether treatment arrives.
Medicines and drug development
When Nature Has Already Run the Experiment: Genetics and the Odds a Drug Target Works
Why a drug target linked to disease by human genetics is about twice as likely to reach approval, and how the strength of that evidence varies.
Medicines and drug development
What an Expiry Date Really Proves: Inside ICH Q1 Stability Testing
What the printed expiry date certifies, and how the consolidated draft ICH Q1 guideline defines the testing that stands behind it.
Medicines and drug development
Wearables in Clinical Trials: What Fit for Purpose Really Requires
How FDA verification and validation expectations decide whether a wearable trial endpoint is real evidence or just a marketing number.
Medicines and drug development
The First AI-Designed Drug Reached Phase 2a: What the Trial Actually Showed
An evidence appraisal of rentosertib's phase 2a IPF trial, separating the AI discovery milestone from what 71 patients over 12 weeks can prove.
Medicines and drug development
The 100 Days Mission and What Makes a Vaccine Platform Truly Ready
A practical guide to appraising vaccine platform readiness against CEPI's 100 Days Mission dimensions instead of taking readiness claims on trust.
Medicines and drug development
Peptide Medicines on the Pharmacy Shelf: What "Approved" Actually Means
Insulin and GLP-1 medicines are peptides that cleared full FDA review. How approved peptide drugs differ from unapproved ones sold online.
Medicines and drug development
Organ-on-Chip Systems: What It Takes to Trust One for a Real Decision
How an organ-on-chip earns regulatory trust: context of use, reference compounds, reproducibility, and measured predictive performance, not lifelike appearance.
Medicines and drug development
Orforglipron: What Does the Oral GLP-1 Evidence in ATTAIN-1 Actually Show?
A neutral appraisal of the ATTAIN-1 phase 3 trial of oral orforglipron, reading its weight and cardiometabolic results against injectable benchmarks.
Medicines and drug development
One Peptide, Four Legal Lives: The Categories US Law Keeps Separate
FDA-approved, 503A/503B-compounded, research-only, and bulk-list peptides are four separate legal states, and one status never implies another.
Medicines and drug development
Inclisiran and the ORION Trials: What Does an LDL Surrogate Endpoint Prove?
What ORION-10 and ORION-11 measured for a twice-yearly siRNA, and why an LDL surrogate endpoint is not the same as proof of fewer heart attacks.
Medicines and drug development
Immunogenicity and Anti-Drug Antibodies: Why the Body Sometimes Fights a Biologic
How labs use a tiered assay strategy to detect anti-drug antibodies, and how to tell a clinically meaningful result from a lab curiosity.
Medicines and drug development
How to Read a Peptide Health Claim Like a Scientist
A five-part reader's test for peptide marketing: the evidence ladder, regulatory status, wording tricks, the "research only" label, and who profits.
Medicines and drug development
How a Shortage List Made Compounded GLP-1 Drugs Legal, and Then Made Them Stop
Compounded semaglutide and tirzepatide were legal only while the FDA listed a shortage. When the lists closed in 2024 and 2025, the copies had to end.
Medicines and drug development
FDA Platform Technology Designation: Reusing Evidence Across a Drug Family
What FDA's Platform Technology Designation is, which technologies qualify, what it speeds up, and the approval limits it does not change.
Medicines and drug development
CAR-T's Boxed Warning for T-Cell Cancers: What the Evidence Does and Does Not Show
A plain-language read of the FDA's 2024 class-wide boxed warning for secondary T-cell cancers after CAR-T therapy, and the limits of the data behind it.
Medicines and drug development
Beyond Animal Testing: What the FDA's New-Approach-Methodologies Roadmap Changes
How the FDA NAMs Roadmap begins replacing animal testing in preclinical safety, why it starts with monoclonal antibodies, and what Year 1 delivered.
Medicines and drug development
Antibody-Drug Conjugates: Following the Molecule From Bloodstream to Tumor Cell
How an ADC's antibody, linker, and payload each work, and why the mechanism alone does not tell you how much a given agent has proven.