Remove Bioequivalency Remove Branding Remove Containment Remove Drugs
article thumbnail

Quality by design with a focus on biosimilars

Pharmaceutical Technology

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

article thumbnail

Amphastar Announces Approval for Glucagon for Injection Kit, 1mg

The Pharma Data

Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Glucagon for Injection Emergency Kit, 1 mg. This further highlights Amphastar’s considerable abilities to bring complex generic drugs to the market, and more specifically, our strong peptide capabilities.”

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

The Mesh of the Generics and the Potential of Emerging Therapies in the Smoking Cessation Market

Delveinsight

Fortunately, there exists FDA-approved therapies and drugs that double the success rates of quitting. Smoking Cessation: What are the drugs available in the market? The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. However, it is possible.

article thumbnail

Cerelle vs Cerazette: Are they really the same?

Druggist

Cerelle and Cerazette are two brands of daily progestogen-only pill (POP), also known as mini-pill. In recent years prescribing of Cerazette in NHS decreased, in place of other brands, including Cerelle. Do generic, and branded drugs produce exactly the same effect? . How can I get Cerazette pill? Can I buy Cerazette? .