The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

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The Pharma Data

NOVEMBER 4, 2020

and Canada) or (484) 365-2865 (International) five minutes prior to the start time. Concert Pharmaceuticals is a clinical stage biopharmaceutical company that is developing small molecule drugs that it discovered through the application of its DCE Platform® (deuterated chemical entity platform).

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The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. Photo: Business Wire).

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LifeSciVC

APRIL 24, 2024

and whether a molecule’s pharmacology can help to mitigate safety risk. Especially for oligo or small molecule discovery and development, it’s important to understand whether there are highly homologous sequences or proteins that may be impacted by a given therapeutic approach. in liver, in CNS)?

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New Drug Approvals

SEPTEMBER 13, 2024

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] “LY2456302 is a novel, potent, orally-bioavailable small molecule kappa-selective antagonist with activity in animal models predictive of efficacy in mood and addictive disorders” Neuropharmacology. 2] Aticaprant is taken by mouth. [1]

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Practical Cheminformatics

JANUARY 8, 2024

Data from 21 million molecules and more than 40,000 assays was securely combined into a multitask model. increase in AUC-PR over internal models. In addition to optimizing potency against a target of interest, we must design selective compounds with optimal pharmacokinetic profiles and a host of other desirable properties.

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The Pharma Data

OCTOBER 18, 2020

Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML.

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The Pharma Data

DECEMBER 15, 2020

Small Molecule Inhibitors. NMD670 is a first-in-class small molecule inhibitor of the muscle specific chloride ion channel, the ClC-1 ion channel. The secondary outcome involves pharmacokinetic endpoints. Oral, Small Molecules. The primary outcome includes safety and tolerability endpoints.

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Agency IQ

JULY 26, 2024

For additional information on this process, sponsors should refer to International Council for Harmonisation (ICH) guidelines Q8, Q9 and Q10 on the development of quality risk management processes, and the steps to conducting the risk assessment. including well before and after product approval). Any CMC changes (e.g.,

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The Pharma Data

SEPTEMBER 15, 2020

Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.

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The Premier Consulting Blog

APRIL 25, 2023

In the US, new small molecule drugs are developed under the requirements of Sections 505(b)(1) and 505(b)(2) of the FFDCA. 4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). 7] Clinical Implications Although the changes implemented by the FDA Modernization Act 2.0

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Agency IQ

DECEMBER 11, 2023

FDA also convened seven Oncologic Drugs Advisory Committee (ODAC) meetings in 2023, offering a candid window into the application review process and the internal deliberations of reviewers grappling to strike a balance between timely access of patients to new products while upholding the rigor of FDA review.

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