Introduction to Dosage Forms and Drug Delivery Flashcards (Week 1 pt 1)

This set of vocabulary flashcards covers the fundamentals of drug development, regulatory history, innovative therapies, and drug discovery methods mentioned in the lecture.

Drug Development Timeline

The period of $10-15 \text{ years}$ required to bring one new medicine to the market.

Average Cost of Drug Development

A total of approximately $2.6 \text{ billion}$ dollars, which includes the cost of failed attempts.

Clinical Trial Success Rate

Only 12\text{%} of new molecular entities that enter clinical trials receive FDA approval.

Personalized Medicine

An innovative medical approach, also known as precision medicine, that tailors healthcare to an individual's specific genetic makeup, environment, and lifestyle.

Genetic Profiling

The core step in personalized medicine where doctors test DNA to find specific biomarkers and genetic mutations.

Pharmacogenomics

The study of how an individual's entire genome influences their response to drugs, often using a saliva test to reveal how the liver metabolizes medication.

Cell Therapy

A type of advanced therapy that uses living cells to repair or replace damaged tissue or fight diseases.

Gene Therapy

An advanced therapy that alters the genetic material in cells to treat or prevent disease.

CRISPR

A groundbreaking tool used to edit DNA easily and precisely for treating diseases and advancing genetics.

Therapeutic Vaccines

Vaccines designed to stimulate the immune system to treat existing diseases, including cancer.

Paragraph IV Certification

A process where the first generic manufacturer to file typically earns $180 \text{ days}$ of market exclusivity for challenging a brand-name drug's patent.

First-in-Class (FIU) Medicine

The first FDA-approved medicine to use a particular mechanism of action or pharmacologic approach to treat a disease.

Orphan Drug Designation

A status for drugs treating rare diseases affecting fewer than $200,000$ U.S. patients, offering financial incentives and $7 \text{ years}$ of market exclusivity.

Federal Food and Drug Act of 1906

The first major law that prohibited false or misleading claims and required labels to disclose dangerous ingredients like heroin or morphine.

Federal Food, Drug and Cosmetic Act (1938)

Legislation that created the FDA and added safety as a requirement for drug approval following over $100$ deaths from a tainted elixir.

Kefauver-Harris Drug Amendments (1962)

Amendments to the 1938 act that required manufacturers to demonstrate both safety and efficacy, and necessitated the submission of an IND.

Drug Efficacy Study Implementation (DESI)

An FDA program created to retroactively evaluate the effectiveness of drugs approved only for safety between $1938$ and $1962$.

Title 21 of the CFR

The section of the Code of Federal Regulations consisting of eight volumes containing regulations administered by the FDA.

Drug Discovery

The first stage of development focused on identifying promising compounds through disease mechanisms, target identification, and screening.

ADME

An acronym for the teams that study how a drug is Absorbed, Distributed, Metabolized, and Eliminated.

High Throughput Screening

A method of scientific experimentation that allows a researcher to screen up to $15,000$ chemical compounds per week.

Molecular Modification

The process of chemically altering an existing drug molecule to enhance its physical, chemical, or pharmacological characteristics like potency or solubility.

Mechanism-Based Drug Design

The development of medications designed to specifically disrupt identified biochemical pathways underlying a disease.

Molecular Graphics

The use of computer-aided design to visualize and analyze drug-target interactions at the atomic level in 3D.

Pharmacogenetics

A field of study focused on how variations in a single gene affect an individual's response to a specific drug.

Proteomics

The study of the proteins produced by genes to provide a comprehensive understanding of cellular functions.

DSP-1181

The first drug molecule created entirely by AI to enter human clinical trials, specifically for the treatment of obsessive-compulsive disorder (OCD).

FDA New Drug Definition

Any drug not recognized among qualified experts as safe and effective, including new combinations of old drugs or new dosage forms.

USAN Council

The United States Adopted Names Council, which is in charge of designating nonproprietary (generic) names for drugs.

Pharmaceutics

The area of responsibility for pharmaceutical scientists and formulation pharmacists focused on the physical and chemical properties of compounds for stable product development.