Abbreviated New Drug Application (ANDA)
An Abbreviated New Drug Application (ANDA) is a streamlined application for the approval of generic drugs in the US. It allows the applicant to reference the safety and effectiveness data of an existing approved drug. This process helps make generic drugs available to the public at a lower cost.
Clinical manufacturing is the process of producing pharmaceuticals for use in clinical trials. It involves strict quality control and adherence to regulatory standards.
Delayed-release tablets are a type of oral solid dosage form designed to release the medication at a specific location in the gastrointestinal tract or after a predetermined period, providing a delayed onset of action.
High Drug Potency
High drug potency refers to the strength or concentration of an active pharmaceutical ingredient (API) in a drug formulation. It indicates the ability of a drug to produce a desired therapeutic effect at a lower dosage, often associated with increased efficacy and reduced risk of side effects.
Oral formulation refers to pharmaceutical products that are designed to be taken by mouth, such as tablets, capsules, or solutions. These formulations are administered through the oral route, allowing the medication to be absorbed into the bloodstream through the gastrointestinal tract for systemic distribution and therapeutic effects.
Oral Solid Dosage
Oral solid dosage refers to pharmaceutical formulations that are taken by mouth in a solid form, such as tablets, capsules, or powders. These dosage forms are designed to be swallowed and dissolved in the gastrointestinal tract, allowing for the systematic delivery of the active pharmaceutical ingredient to the body.
Pharmaceutical Contract Manufacturing
Pharmaceutical contract manufacturing is when a drug company hires a third-party manufacturer to produce pharmaceutical drugs on their behalf. This outsourcing can include drug development, manufacturing, and regulatory compliance. It allows companies to reduce costs, speed up production, and focus on their core missions. The practice is common in the pharmaceutical industry.
A sustained-release tablet is a pharmaceutical formulation designed to release the medication gradually over an extended period. It delivers a controlled and steady amount of the active ingredient into the body, prolonging its therapeutic effects and reducing the frequency of dosing.