Camargo

NOVEMBER 11, 2020

Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Unpacking the (Black) Box: Antares Licenses Urology Product with Boxed Warning. of hyponatremia, or low blood sodium levels. In October, the U.S.

Development 242

Development Bioequivalency Generic Drugs Production 242

Pharmaceutical Technology

FEBRUARY 23, 2023

Quotient Sciences helps biotech and pharma customers in the development and optimization of drug products. Our chemists and formulation scientists review the properties of new drug candidates and “work their magic” to develop formulations that improve the exposure profile of the compound.

Development 246

Development Drugs Bioavailability In-Vivo 246

Drug Patent Watch

JANUARY 14, 2025

But how do companies develop these cost-effective alternatives? Generic drug manufacturers are taking a similar approach by developing multiple drugs simultaneously[1]. ”[2] This study not only addressed the ATA’s concerns but also highlighted the power of real-world evidence in generic drug development and regulation.

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Generic Drugs Development Drugs Manufacturing 79

Camargo

DECEMBER 22, 2021

Informed by today’s competitive drug development landscape, as well as by the sponsor’s strategic goals and capabilities, a portfolio analysis involves assessing product concept and differentiation, strategic planning, factoring in unmet patient needs, and estimating timelines and expenses. Fine-Tuning Strategic Assessment.

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Bioequivalency Production Genotoxicity In-Vivo 169

Camargo

FEBRUARY 10, 2021

Drug development is an extremely cumbersome process, requiring the testing of an agent from in vitro studies to in vivo studies to in silico modeling. Pharmacokinetics (PK) and bioequivalence (BE) studies serve as the foundation of determining the fate of drug products. Approaches to Pharmacokinetic Analysis.

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Production Bioavailability In-Vivo In-Vitro 133

FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. As part of its Generic Drug User Fee Amendments of 2022 (“GDUFA III”) Commitment, FDA agreed to expedited development of PSGs.

Bioequivalency 59

Bioequivalency Generic Drugs Packaging Packaging 59

Drug Patent Watch

DECEMBER 11, 2024

These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product quality. They provide recommendations on the design of in vitro and in vivo studies. ” – Dr.

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Generic Drugs Production Development Bioequivalency 92