Bioavailability Bioequivalency Production 
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.
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.
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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?
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.
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.
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 FDA Publishes Draft Guidance on Adverse Drug Experience Reporting for INDs and BA/BE Studies .
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.
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