One of the hardest parts of transitioning into a new industry is learning the lingo. Acronyms, in particular, can make crucial documents or conversations feel more like alphabet soup than meaningful communication.
For the initiated, however, acronyms streamline professional communication. If you work or aspire to work in the pharmaceutical industry, it can be much quicker to write or speak a few crucial acronyms that all your colleagues understand.
Here are five acronyms you should know if you work in pharma.
IQ OQ PQ
IQ OQ PQ refers to a standard of validation for the installation of equipment. Since pharmaceutical manufacturing involves sophisticated machinery, IQ OQ PQ comes up a lot in the pharma industry. Every pharma manufacturer needs established IQ OQ PQ practices in place to maintain compliance with regulations.
So what does the acronym stand for? It’s actually three short acronyms, broken down as follows:
- IQ—Installation Qualification. This is the process of validating that the equipment was installed properly. This includes installation to factory specifications, as well as leveling and availability of sufficient power and space for the machinery to operate.
- OQ—Operational Qualification. This is the process of determining that the machinery is operating in accordance with the manufacturer’s specifications. Note that this isn’t the same thing as testing the equipment under operating conditions. It involves making sure that different components operate within factory parameters and produce repeatable results.
- PQ—Performance Qualification. This is the validation of the operational capacity of the machinery under production conditions. Note that PQ may be performed before the equipment is placed into service for actual production.
IQ OQ PQ is usually performed at the time of installation, but may be repeated on a regular basis or after upgrades and maintenance.
This article from Dickson notes that IQ OQ PQ is of particular relevance to pharmaceutical manufacturers.
CTA
In other industries, “CTA” means “call to action.” In the pharmaceutical industry, however, CTA refers to “clinical trial application.”
A CTA is submitted to the regulatory bureau with jurisdiction over the pharma company, like the Food and Drug Administration (FDA). An approved CTA authorizes the pharma company to begin clinical trials of a new drug. Proper clinical testing is one of the most important quality-assurance steps for pharmaceutical companies.
CTAs usually include a comprehensive description of the experimental drug and a breakdown of the methods and goals of the trial.
Regulators will use the CTA to assess the validity of the trial and approve or reject it. Factors they look for in a CTA include the risk/reward ratio, the properties of the drug, the quality of supporting data, and the acceptability of the testing parameters like test subjects, dosage, indications, and efficacy.
MAD
“M.A.D.” stood for “mutually-assured destruction” during the Cold War. In the pharmaceutical industry, MAD refers to “multiple ascending dose.” It is a kind of study used in the development of a drug wherein the test subject receives multiple doses of a drug.
“Ascending” means that each new cohort of subjects gets a larger dose of the drug. The goal of MAD is to assess the accumulation potential and dose proportionality of the drug, to help establish the maximum tolerated dose (MTD) of the drug, another important characteristic of a drug that must be established before it can be approved by regulatory bodies like the FDA.
MAD can be contrasted with a single ascending dose (SAD) study, an earlier phase where test subjects receive only one dose of the drug, with each cohort of test subjects receiving a larger dose than the last cohort. MAD and SAD may both play a role in a clinical trial to establish the MTD. There you have it—three acronyms for the price of one.
NDA
Far from representing “non-disclosure agreement,” in the pharma industry NDA stands for new drug application. Whereas the CTA is the pharma company’s pitch to regulators to approve a clinical trial of the drug, the NDA is the pharma company’s application to bring a drug to market.
Regulators like the FDA must approve the pharma company’s NDA before the drug can be marketed to the public. The path from discovery to NDA is long, usually spanning multiple years. Only 30% of all candidate drugs make it to the point of an approved NDA.
The NDA must present the entire history of the drug, through discovery and clinical trials. An NDA must include:
- Manufacturing and patent information.
- Proposed uses.
- Safety specifications.
- Design compliance reports.
- Conclusions from clinical trials.
- Proposed labeling.
- Propensity for abuse.
The goal of the lengthy and cumbersome NDA process is to maintain public trust in the pharmaceutical industry and safeguard public health, making sure that the drugs that make it to market are thoroughly tested and safe for consumers to use as directed.
SAE
An SAE is a serious adverse event. An SAE during a clinical trial is a serious hindrance to that drug’s path to approval, in addition to potentially causing tragic loss of health or life.
Types of SAEs that might occur during a drug trial include:
- Death of a test subject.
- Threat to the life of the test subject.
- Inpatient hospitalization of a test subject.
- Prolonging an existing hospitalization of a test subject.
- Causing a congenital birth defect.
- Necessitating intervention to prevent permanent damage.
Clinical investigators are required by law to report any SAEs that occur during a clinical trial, but regulators warn that SAEs may be insufficiently reported in publicly-available records of the trial.
An obvious consequence of an SAE may be that the drug’s path to approval may be slowed or stopped altogether, resulting in losses for the pharmaceutical company. However, the penalties for lack of compliance and loss of public trust represent a heavy responsibility on pharmaceutical companies, compelling them to do the right thing.
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This is by no means a comprehensive list of the acronyms newcomers to the pharmaceutical industry will encounter. However, it represents an important primer of the basics, especially easily-confused terms. You don’t want to be designing calls to action when someone needs a clinical trial application.
