Pharmaceutical Technology

OCTOBER 28, 2022

According to Dr Mansoor Amiji of Northeastern University: “Instead of relying on product quality as a readout after the product is made, you start to implement these procedures into the product production processes. Practising QbD in biosimilar product development.

Bioequivalency 130

Bioequivalency Production Contamination Branding 130

XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. What is an Interchangeable Biological Product? What is a Biosimilar?

Production 78

Production Insulin Branding Generic Drugs 78

Pharmacy Checkers

FEBRUARY 14, 2020

Many readers complained that it just wasn’t cutting it compared to the brand name version. In fact, they asked ConsumerLab.com, sister company to PharmacyChecker, to test the product. Sure enough, ConsumerLab.com discovered that the 300mg version was clearly not bioequivalent. Just switch back to the brand!”

Branding 62

Branding FDA Approval Pharmacy Bioequivalency 62

The Pharma Data

DECEMBER 28, 2020

Amphastar’s newly approved synthetic peptide product was determined by the FDA to be bioequivalent and therapeutically equivalent to Eli Lilly’s Glucagon Emergency Kit for Low Blood Sugar, which has a recombinant DNA (rDNA)-origin. Additionally, the Company sells insulin API products. ” According to IQVIA, the U.S.

Bioequivalency 52

Bioequivalency Production Sales Marketing 52

Delveinsight

FEBRUARY 5, 2021

This means that the companies generating revenue out of their tobacco products are affluent enough to collectively spend USD 1 million every hour on advertising their products. The USFDA’s Center for Drug Evaluation and Research regulates and ensures the safety and effectiveness of these products. Generics in the Market.

Marketing 52

Marketing FDA Approval Branding Production 52

Druggist

MARCH 25, 2021

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? . Summary of the post: Cerelle vs Cerazette: are they the same?

Branding 98

Branding Bioequivalency Pharmacy Generic Drugs 98

Drug Patent Watch

JANUARY 22, 2025

The Science Behind Generic Drug Bioequivalence: Separating Fact from Fiction As a healthcare professional or someone simply looking to stay informed, you've likely heard the term "bioequivalence" thrown around when it comes to generic drugs. But what does it really mean, and how does it impact the medications we take?

Bioequivalency 81

Bioequivalency Generic Drugs Drugs Branding 81

Drug Patent Watch

DECEMBER 11, 2024

One of the key tools that generic drug manufacturers rely on to navigate the complex regulatory environment is the FDA’s Product Specific Guidances (PSGs). Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S. ” – Dr.

Generic Drugs 95

Generic Drugs Production Development Bioequivalency 95

Drug Patent Watch

JANUARY 7, 2025

Generic drugs are pharmaceutical products that contain the same active ingredients as their brand-name counterparts. They’re designed to be bioequivalent, meaning they have the same dosage, strength, route of administration, quality, and intended use as the original brand-name drug. What Are Generic Drugs?

Generic Drugs 89

Generic Drugs Drugs Branding Bioequivalency 89