Can you imagine everything that goes into bringing drugs to the market? There are so many tests, so many controls, so many variables, which is why it can take years before a drug is FDA approved. The side effects of the drugs must be tracked and monitored and then retested again and again. All of this is for our own benefit. When my doctor prescribes me a prescription I want to know that it has been thoroughly tested. It is difficult to understand the entire process of the pharmaceutical industry. Learning some terms can help you better understand what they are doing and how things work.
Terms taken from DFE pharma
A drug for which the patents protecting the originator product have expired (or may be challenged). Generic products are pharmaceutically equivalent to a reference listed drug (same drug substance, same route of administration, same dosage form and same strengths) and are also therapeutically equivalent (typically bioequivalent for oral solid dosage forms).
Hydrofluoroalkane (HFA) Propellants used in current pressurized metered dose inhalers (pMDI) are HFAs. They replaced the ozone depleting chlorofluorocarbons. The two propellants used in MDI formulations are HFA 134a (1,1,1,2-tetrafluoroethane) and less commonly HFA 227 (1,1,1,2,3,3,3-heptafluoropropane).
In-vitro In-vivo correlation (IVIVC)
A mathematical means of establishing the relationship between in-vitro dissolution data of a dosage form and an in-vivo response elicited by that dosage form, such as plasma level of drug or a derived drug absorption profile. A strong IVIVC can in some circumstances support a biowaiver.
New Drug Application (NDA)
The process by which a pharmaceutical company requests permission to manufacture and sell a new drug in the USA. The NDA differs from the ANDA in that it contains extensive data on safety and efficacy of the proposed new drug.
The study of the time course of the way the body handles drugs. There are four essential processes following a persons ingestion of a tablet or other oral dosage form, collectively known as ADME processes (Absorption of the drug from the gut; Distribution of the drug into other body tissues; Metabolism of the drug to other chemicals (metabolites) and Elimination of the drug from the body). This time course is typically followed by taking blood samples from volunteers at time intervals following swallowing a tablet, and measuring the amount of drug and / or metabolites in the plasma. A plot can be constructed of plasma concentration against time from which various PK parameters such as Cmax, Tmax and AUC can be derived. Other fluids may be analyzed, for example urine.
The last term is probably one of the more relevant terms to the community. Knowing how long it takes a drug to pass through the body, and how much is absorbed by the body is very important. It can effect everyone differently and cause very different side effects. It is important that safe drugs are put on the market and so the drugs must go through strenuous testing.
The more we know about the pharmaceutical industry and how they test and quantify their finding the better off the community is. The side effects of the drugs can be very dangerous and it is important that the FDA has as much information on these drugs as possible. So keep informed on what’s going on and learn some more terms!