What are complex drug products?
What are complex drug products?
What is a complex generic drug product?
- A product with:
- Complex drug-device combination products (e.g., auto injectors, metered dose inhalers); and.
- Other products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement.
What are complex generic products?
A complex generic is a generic that could have a complex active ingredient, complex formulation, complex route of delivery, or complex drug device combinations. The European Medicines Agency (EMA) defines a generic drug as a medicine that is developed to be the same as a medicine that has already been authorised.
What are complex generics examples?
Complex generic products earned their name because many have complex active ingredients, dosage forms, routes of administration, or drug-device combinations. Examples of complex products include inhalers, topical products, and extended release injectables.
What are complex Apis?
The US Food and Drug Administration (US FDA) defines complex generics as products having intricacy associated with an active pharmaceutical ingredient(s) (API), formulation process, route of delivery, or drug-device combination.
What is the most complex drug?
This is quite a synthetic chemistry accomplishment: the halichondrin derivative E7130 has been synthesized on an 11-gram scale by the Kishi group (open-access paper).
What are complex injectables?
A complex injectable is a product that has a complex active ingredient, complex formulation, complex route of delivery, or complex drug device combinations.
What is a biosimilar agent?
A biosimilar, or biosimilar drug, is a medicine that is very close in structure and function to a biologic medicine. A biologic, or biologic drug, is a medicine made in a living system, such as yeast, bacteria, or animal cells.
How does complexation affect the drug action?
➢ The action of drug to remove the toxic effect of metal ion from the human bodies is through the complexation reaction. ➢ It has been seen that in some instance complexation can also lead to poor solubility or decreased absorption of drug in the body, which decreases the bioavailability of drug in the blood.
What are injectable products?
Injectable drugs
- ACETAMINOPHEN injectable.
- AMPICILLIN injectable.
- ARTESUNATE injectable.
- DIAZEPAM emulsion.
- DIAZEPAM solution.
- DICLOFENAC injectable.
- HEPARIN injectable.
- ISOSORBIDE DINITRATE injectable.
Why do liposomes form?
They typically form after supplying enough energy to a dispersion of (phospho)lipids in a polar solvent, such as water, to break down multilamellar aggregates into oligo- or unilamellar bilayer vesicles. Liposomes can hence be created by sonicating a dispersion of amphipatic lipids, such as phospholipids, in water.