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. Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product. In October, the U.S.

Development 242

Development Bioequivalency Generic Drugs Production 242

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. Why Conduct a Portfolio Analysis?

Bioequivalency 169

Bioequivalency Production Genotoxicity In-Vivo 169

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 Discovery World

AUGUST 22, 2023

Originator pharma companies are developing ever more complex products, which are transforming the medical landscape, but their cost places an increasing burden on healthcare budgets worldwide. This includes products with complex active ingredients or complex formulations, drug-device combination products, or complex routes of delivery.

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Production Bioequivalency In-Vivo In-Vitro 52

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. 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.

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Production Bioavailability In-Vivo Bioequivalency 133

Pharmaceutical Technology

FEBRUARY 23, 2023

Biopharmaceutics is a scientific discipline that examines the interrelationship of the physicochemical properties of the drug, the dosage form in which the drug is given, and the route of administration on the rate and extent of systemic drug absorption ( Applied Biopharmaceutics and Pharmacokinetics, Shargel, Wu-Pong and Yu, 5th Edition ).

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Development Drugs Bioavailability In-Vivo 246