Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Previously natural products have provided the source of up to 90% of macrocyclic drugs, not surprising given that 20% of natural product derived ring systems are macrocyclic [2]. Garcia Jimenez et al.,

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Metabolite Tales Blog

JULY 5, 2023

Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders. Previously natural products have provided the source of 80-90% of macrocyclic drugs, not surprising given that 20% of natural product derived ring systems are macrocyclic. [2] Garcia Jimenez et al.,

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Metabolic Stability Drugs FDA Approval Treatment 52

Agency IQ

SEPTEMBER 15, 2023

The monographs functioned as rule books for specific classes of OTC drugs, describing active ingredients, doses, indications, labeling and tests requires for covered OTC products to be generally recognized as safe and effective (GRASE). developing or amending a monograph) or sponsor-initiated operations (e.g.,

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Agency IQ

DECEMBER 11, 2023

BY RACHEL COE, MSC | DEC 6, 2023 5:27 PM EST The push and pull: Trends in oncology After the creation of the Accelerated Approval Pathway, several policies in the early 2000s were put in place with the goal of getting cancer products to patients faster. OCE has also been busy this year.

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Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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The Premier Consulting Blog

JUNE 18, 2023

Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials.

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The Pharma Data

OCTOBER 15, 2020

OncoSec Medical – Sanda Aung was named chief clinical development officer for OncoSec Medical Incorporated. Trevi Therapeutics – Shashank Rohatagi was named vice president of Pharmacology and Clinical Phrarmacokinetics. She was also CSO at Adjuvant Partners. Farrell Simon joins Trevi as head of U.S.

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Pharmaceuticals Clinical Pharmacology Medical Schools Therapies 52

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. The draft guidance states that only one 90-minute pre-BLA meeting will typically be granted for a specific product or indication planned for an original marketing application.

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