Glossary of Pharmaceutical Development Terms

We have compiled a list of common pharmaceutical development terms that we use and work with day-to-day as an award-winning CDMO. Please contact us if you have any questions or need any additional information.

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.

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CDMO (Contract Development and Manufacturing Organization)

A Contract Development and Manufacturing Organization (CDMO) provides comprehensive services for the pharmaceutical industry, including the development, manufacturing, and scaling of drug products. These organizations are equipped to handle all stages of drug development, from initial concept through to commercial manufacturing, often offering additional support for regulatory compliance and quality assurance. CDMOs are distinct from Contract Manufacturing Organizations (CMOs) by offering both development and manufacturing services, making them a versatile partner for pharmaceutical companies aiming to streamline their operations and mitigate risk throughout the drug development process.

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Clinical Manufacturing

Clinical manufacturing is the process of producing pharmaceuticals for use in clinical trials. It involves strict quality control and adherence to regulatory standards.

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Delayed-Release Tablet

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.

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Oral Formulation

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.

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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.

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Orphan Drug Designation

Orphan Drug Designation is a status granted to drugs developed for rare diseases affecting fewer than 200,000 people in the USA, or when their development costs exceed potential profits. Established by the Orphan Drug Act of 1983, it offers benefits like market exclusivity for seven years post-approval, significant tax credits, clinical research subsidies, and regulatory incentives, including fee waivers and FDA assistance, to encourage the development of treatments for rare conditions.

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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.

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Pharmaceutical Quality Assurance

Pharmaceutical Quality Assurance ensures the safety, efficacy, and reliability of drug products. It involves comprehensive monitoring and regulation of the manufacturing process, from raw material procurement to the final product distribution, adhering to standards that protect public health and comply with regulatory requirements.

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Small Molecule Drug

Small molecule drugs are pharmaceutical compounds with low molecular weights, facilitating their ability to pass through cell membranes. They interact with specific biological targets to modulate activity, often used in treating a variety of diseases due to their stability, predictable manufacturing, and versatile dosing forms.

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Sustained-Release Tablet

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.

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