XTalks

NOVEMBER 6, 2024

The stable gel matrix holds multiple ingredients, offering targeted release and enhanced bioavailability while optimizing patient experience. To address growing demand, Gelteq is expanding production capacity with a Good Manufacturing Practice (GMP)-certified facility, aiming for scalable, reliable output by 2025.

Drug Delivery 104

Drug Delivery Drugs Bioequivalency Bioavailability 104

Camargo

FEBRUARY 10, 2021

Given that it can take up to 20 years for a final product to be approved, it is unsurprising that drug attrition rates are very high. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. Pharmacokinetic Modeling: Non-Linear Mixed Effects Modeling.

Production 133

Production Bioavailability In-Vivo In-Vitro 133

Camargo

DECEMBER 22, 2021

One of Camargo’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of the scientific, medical, regulatory, and commercial viability of each product within a sponsor’s portfolio. Each product is unique, and so is the associated development strategy. Why Conduct a Portfolio Analysis?

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

FDA Law Blog

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

Drug Delivery 105

Drug Delivery Drugs Bioequivalency Production 105

Camargo

JULY 8, 2021

As required by components of the 21 st Century Cures Act and the FDA Reauthorization Act, the FDA has sought to promote Patient-Focused Drug Development considerations into regulatory decision making, including product application approvals. FDA Publishes Draft Guidance on Adverse Drug Experience Reporting for INDs and BA/BE Studies .

Development 130

Development Bioequivalency Gene Expression Drugs 130

FDA Law Blog

JULY 6, 2021

Circuit, their client Nostrum Laboratories sought judicial review after FDA agreed to allow a certain type of study to establish bioequivalence for generic theophylline, Nostrum conducted those studies, and then FDA issued a CRL asking for new, time-consuming, expensive studies of a different sort.

Bioequivalency 52

Bioequivalency Bioavailability Drugs Regulation 52

The Pharma Data

APRIL 11, 2023

Dose proportionality and bioequivalence studies demonstrate once-daily AUSTEDO XR is therapeutically equivalent to twice-daily AUSTEDO ® (deutetrabenazine) tablets The U.S. Bioequivalence and relative bioavailability were established between the once-daily and twice-daily tablet formulations, with no new safety findings emerging.

Bioequivalency 40

Bioequivalency FDA Approval Medicine Bioavailability 40