Topic
Diabetes therapies and drug development
How diabetes medicines and new therapies are developed, tested, and brought to the clinic.
This page collects every article by Dr. Damon Tojjar in this topic. For all topics see browse by topic, and for the source-anchored record see damontojjar.com/record.
Articles in this topic (22)
- Bioequivalence for Narrow Therapeutic Index Drugs: How Tight Is Tight Enough
Bioequivalence is not a single fixed standard, and grasping that is the key to judging when a generic substitution is scientifically supported. For most oral drugs,...
- Biosimilar Interchangeability: Why Switching Studies May No Longer Be Required
The FDA has proposed dropping routine switching studies for interchangeable biosimilars, letting sponsors instead justify interchangeability from comparative...
- Decentralized Clinical Trials: What the FDA's 2024 Final Guidance Allows and Guards Against
The FDA's September 2024 final guidance, titled "Conducting Clinical Trials With Decentralized Elements," permits sponsors to move trial activities off the...
- How a Clinical Trial Protocol Is Designed, Section by Section
A clinical trial protocol is the full written plan for a study: it states the question the trial will answer, defines exactly who can enroll, describes the...
- How a Companion Diagnostic Is Developed Alongside a Drug
A companion diagnostic is a test that decides who should receive a particular drug, built and validated alongside that drug rather than bolted on afterward. It...
- How a Drug Gets Its Label and Its Approved Indication
A drug label is the official, regulator-approved account of what a medicine is, who it is for, and how it should be used. Its central promise is the approved...
- Biologic Medicines vs. Pills: Why Protein Drugs Are Made and Used Differently
What makes a biologic different from a pill?A biologic is a large, protein-based medicine grown inside living cells, while a traditional pill is a small molecule...
- How Combination Drug Therapies Are Developed
A combination therapy is built when two active drugs work better together than either does alone, and developing one means proving that the pairing adds something...
- How the Right Dose of a Medicine Is Worked Out
How is the right dose of a medicine decided?The right dose of a medicine is the amount that gives enough of the wanted effect while keeping unwanted effects...
- How Drug Manufacturing Quality Is Controlled: GMP in Plain Terms
Good Manufacturing Practice, or GMP, is the set of rules that makes sure every dose of a medicine is what the label says it is: the right drug, the right strength,...
- How GLP-1 and GIP Work Together to Manage Blood Sugar and Appetite
GLP-1 and GIP are two hormones your gut releases within minutes of a meal, and their shared job is to tell the rest of the body that food is arriving so the...
- How GLP-1 and GIP Medicines Work as Science and What the Trials Measured
What these drugs are, in two sentencesGLP-1 and GIP medicines are engineered copies of gut hormones that amplify insulin release only when glucose is high, slow the...
- How Insulin Therapy Works: A Precise Tool That Mimics the Body's Own Rhythm
How does insulin therapy actually work?Insulin therapy works by replacing a hormone the body can no longer make in the right amount or use in the right way,...
- ICH M13A and How the World Is Standardizing Generic Bioequivalence Testing
When a generic tablet reaches a pharmacy, someone had to prove it delivers its active ingredient into the bloodstream much like the original brand. That proof is...
- Beyond the Maximum Tolerated Dose: What Project Optimus Changed in Cancer Drug Trials
Project Optimus is an initiative of the FDA's Oncology Center of Excellence, launched in 2021, that ended oncology's decades-long habit of picking a dose at the...
- Designing Quality In: What Critical-to-Quality Factors Mean Under ICH E8(R1)
Under ICH E8(R1), quality in a clinical study is defined as "fitness for purpose," and it is meant to be built into the design rather than checked for once the data...
- Understanding Basal and Bolus Insulin: How Two Patterns Mimic the Body
What do basal and bolus insulin actually mean?Basal insulin is the steady background supply the body needs all day and night, while bolus insulin is the larger,...
- Understanding GLP-1 Based Therapies: The Idea Behind Borrowing the Body's Own Signals
What are GLP-1 based therapies, in one idea?GLP-1 based therapies are treatments built to extend a signal the body already makes. After you eat, the gut releases a...
- From Phase 2 to Phase 3: The Go or No-Go That Decides a Drug Program
The move from phase 2 to phase 3 is a commitment decision, and it turns on three questions asked together: did phase 2 find a dose worth carrying forward, is the...
- What Informed Consent Really Means in a Clinical Trial
Informed consent in a clinical trial is a continuing conversation, not the moment a pen touches paper. Before you agree to take part, and for as long as you remain...
- Pharmacokinetics and Pharmacodynamics: What the Body Does to a Drug, and Back
What do pharmacokinetics and pharmacodynamics mean?Pharmacokinetics is what the body does to a drug, and pharmacodynamics is what the drug does to the body. The...
- What Pharmacovigilance Does: Watching a Medicine's Safety After Approval
Pharmacovigilance is the science and practice of watching a medicine's safety for as long as people take it, so that effects too rare or too slow to appear in...