Pharma pillar · 24 definitions
Pharma & drug development
Clear, citable definitions of the standards, regulation and science behind medicines — from Good Clinical Practice and Good Manufacturing Practice to the FDA, the drug-approval pathway and the pharmacology of how drugs act. A regulatory and research reference, written to be accurate and strictly non-clinical.
The standards that govern medicines
Two quality frameworks anchor the field. Good Clinical Practice (GCP) governs how trials in people are designed and run, protecting participants and data integrity; Good Manufacturing Practice (GMP) governs how medicines are made to a consistent quality. Both sit within the international ICH guideline system that regulators worldwide draw on.
Regulation and the path to approval
Regulators decide whether a medicine can reach patients. The FDA in the United States reviews evidence through a defined approval process, monitors safety after approval through pharmacovigilance, and can issue recalls when problems arise. These pages explain those processes at an educational level.
The science of how drugs act
Underneath the regulation is pharmacology. Pharmacokinetics describes what the body does to a drug — its absorption, distribution, metabolism and excretion — while pharmacodynamics describes what the drug does to the body. The definitions below cover the standards, the regulators and the science together.
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Pharma & drug development definitions
Good Clinical Practice
What is Good Clinical Practice (GCP)?
Good Clinical Practice (GCP) is the international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials. It protects participants’ rights and safety and assures the integrity of the data a trial produces.
Read →Good Manufacturing Practice
What is Good Manufacturing Practice (GMP)?
Good Manufacturing Practice (GMP) is the quality system that ensures medicines are consistently produced and controlled to the standards required for their intended use. It governs everything from facilities and equipment to records and testing.
Read →FDA
What is the FDA (Food and Drug Administration)?
The FDA (US Food and Drug Administration) is the federal agency that regulates drugs, biologics, medical devices, food and related products. Its role in research is reviewing the evidence behind new medicines and deciding whether they may be marketed.
Read →FDA approval process
What is the FDA drug approval process?
The FDA approval process is the staged pathway a new medicine follows from laboratory research to market authorisation. It runs from preclinical testing through an IND, the clinical-trial phases, and an NDA or BLA submission that the FDA reviews.
Read →FDA drug recalls
What are FDA drug recalls?
An FDA drug recall is the removal or correction of a marketed product that is defective or potentially harmful. The FDA classifies recalls by the level of risk they pose — Class I, II or III — and most are initiated voluntarily by the manufacturer.
Read →Pharmaceutical industry
What is the pharmaceutical industry?
The pharmaceutical industry researches, develops, manufactures and markets medicines. Its defining activity is a long research-and-development pipeline that turns scientific discoveries into approved, quality-controlled products for patients.
Read →Drug development
What is drug development?
Drug development is the end-to-end process of turning a promising compound into an approved medicine. It runs from target identification and preclinical testing through the clinical-trial phases to regulatory review, with attrition at every stage.
Read →Drug discovery
What is drug discovery?
Drug discovery is the early-stage science of finding candidate compounds that might become medicines. It covers identifying a biological target, screening molecules for activity, and optimising the most promising “leads” into development candidates.
Read →Pharmacology
What is pharmacology?
Pharmacology is the science of how drugs interact with biological systems. It has two main branches: pharmacokinetics, which describes what the body does to a drug, and pharmacodynamics, which describes what the drug does to the body.
Read →Pharmacokinetics
What is pharmacokinetics?
Pharmacokinetics (PK) is the study of what the body does to a drug over time. It describes how a drug is absorbed, distributed, metabolised and excreted — the ADME processes — using measures such as half-life and clearance.
Read →Pharmacodynamics
What is pharmacodynamics?
Pharmacodynamics (PD) is the study of what a drug does to the body. It examines how drugs act on receptors and other targets to produce effects, including the concepts of agonists and antagonists and the dose–response relationship.
Read →ADME
What is ADME?
ADME is the acronym for the four pharmacokinetic processes a drug undergoes in the body: absorption, distribution, metabolism and excretion. Together they describe how a drug enters, moves through, is transformed by and leaves the body.
Read →Bioavailability
What is bioavailability?
Bioavailability is the fraction of an administered dose of a drug that reaches the systemic circulation in an active form. It is a key pharmacokinetic concept, and is described as either absolute or relative depending on the comparison made.
Read →Pharmacovigilance
What is pharmacovigilance?
Pharmacovigilance is the science of monitoring the safety of medicines after they are approved and in use. It collects and analyses reports of adverse events, detects safety signals, and supports action to manage risks.
Read →Toxicology
What is toxicology?
Toxicology is the study of the adverse effects of substances on living organisms. In drug development it underpins preclinical safety testing, characterising potential harms before a candidate medicine is given to people.
Read →Regulatory affairs
What is regulatory affairs?
Regulatory affairs is the profession and function that manages a company’s interactions with medicines regulators across a product’s lifecycle — from development and submission to approval, manufacturing oversight and post-market changes.
Read →New Drug Application
What is a New Drug Application (NDA)?
A New Drug Application (NDA) is the formal request a company submits to the FDA to approve a new drug for marketing in the United States. It assembles all the evidence from discovery and clinical testing into one comprehensive package for review.
Read →Generic drug
What is a generic drug?
A generic drug is a medicine that contains the same active ingredient as an approved brand-name product and is shown to be bioequivalent to it. Generics typically reach the market after the original’s patents expire, via an abbreviated FDA application.
Read →Biosimilar
What is a biosimilar?
A biosimilar is a biological medicine that is highly similar to an already-approved reference biologic, with no clinically meaningful differences in safety or effectiveness. It is called “similar”, not identical, because biologics cannot be copied exactly.
Read →Orphan drug
What is an orphan drug?
An orphan drug is a medicine developed to treat a rare disease — one affecting relatively few people. Because the small patient population can make development commercially unattractive, regulators grant orphan designation with incentives to encourage it.
Read →Drug half-life
What is drug half-life?
Drug half-life is the time it takes for the concentration of a drug in the blood plasma to fall by half. It is a core pharmacokinetic parameter that describes how quickly a drug is removed from the body — a concept, not a dosing instruction.
Read →Therapeutic index
What is the therapeutic index?
The therapeutic index is a measure of a drug’s safety margin: the ratio between the dose that produces toxicity and the dose that produces the desired effect. A wider index means a larger gap between effective and harmful exposures — a concept, not dosing advice.
Read →Dose–response curve
What is a dose–response curve?
A dose–response curve describes how the magnitude of a drug’s effect changes as the dose increases. It is a foundational pharmacology concept that underpins the ideas of efficacy, potency and EC50 — a research tool, not dosing advice.
Read →Active pharmaceutical ingredient
What is an active pharmaceutical ingredient (API)?
An active pharmaceutical ingredient (API) is the component of a medicine that produces its intended biological effect. The rest of a product is made up of excipients — inactive ingredients that deliver, stabilise or shape the API into a usable form.
Read →Common questions
Pharma FAQ
What is Good Clinical Practice (GCP)?+
Good Clinical Practice is an international ethical and scientific quality standard — set out in ICH guideline E6 — for designing, conducting, recording and reporting clinical trials. It protects the rights, safety and wellbeing of participants and assures the credibility of trial data.
What does the FDA do?+
The US Food and Drug Administration is the federal agency that regulates the safety and effectiveness of medicines, biologics, medical devices and food. In drug development it reviews evidence from studies and decides whether a product may be marketed. These pages describe that role at an educational level.
What is the difference between pharmacokinetics and pharmacodynamics?+
Pharmacokinetics is what the body does to a drug — its absorption, distribution, metabolism and excretion (ADME). Pharmacodynamics is what the drug does to the body — how it produces its effects through receptors and dose–response relationships. The two together describe a drug's behaviour.
Is this medical or treatment advice?+
No. These pages define the regulatory frameworks, development processes and pharmacology concepts behind medicines at an educational level. They are not medical advice and do not cover diagnosis, dosing, treatment choices or specific products.
How does this relate to CASRAI standards?+
CASRAI is a research-standards body. Drug development is one of the most heavily standardised areas of research — governed by frameworks such as ICH-GCP and GMP — making it a natural fit for a reference focused on the standards and quality systems that make research trustworthy.
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