Camargo

JULY 8, 2021

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. At Camargo, we have worked with hundreds of investigators who have found new targets for established drugs.

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Development Bioequivalency Gene Expression Drugs 130

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?

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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. 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. that could arise from that same population.

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Production Bioavailability In-Vivo Bioequivalency 133

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 Bioavailability Medicine 40

FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA).

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Trials Clinical Trials Clinical Trials Drugs 59

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