The Pharma Data

OCTOBER 27, 2020

million in 2015. million Series A gives it the capital to take their PRTX007 candidate into a short-term pharmacokinetic, pharmacodynamic and tolerability study, followed by a clinical proof-of-concept in an acute viral disease setting. The $71 million funding includes an initial financing of $32.5 In the U.S., The company’s $27.4

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The Pharma Data

DECEMBER 3, 2020

Safety and Pharmacokinetics of Antisense Oligonucleotide STK-001 in Children and Adolescents with Dravet Syndrome: Single and Multiple Ascending Dose Design for the Open-Label Phase 1/2a MONARCH Study. The primary endpoints are safety, tolerability and pharmacokinetic (PK) profile of STK-001 in Dravet syndrome patients. About STK-001.

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The Pharma Data

JULY 29, 2021

Additionally, pharmacokinetic/pharmacodynamic modeling showed that greater relative amyloid plaque clearance was correlated with greater clinical benefit. In the US alone, there was an increase of 8 million new caregivers from 2015 to 2020.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. Four comments were submitted to the docket established for the 2015 Petition. The panel also heard from the authors of the 2007 meta-analysis that found phenylephrine to be ineffective as well as the 2015 Citizen Petition.

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Molecular Design

MAY 11, 2019

back in 2015 and you may find this review of that seminal contribution to the drug design literature to be informative. Design decisions in lead optimization are typically supported by assays for a range of properties such as solubility, permeability, metabolic stability and off-target activity as well as pharmacokinetic studies.

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The Pharma Data

OCTOBER 14, 2020

Lanifibranor is believed to be the first drug candidate to be granted this status for the treatment of NASH since January 2015. Food and Drug Administration granted Breakthrough Therapy designation to France-based Inventiva’s experimental NASH treatment lanifibranor.

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Agency IQ

FEBRUARY 23, 2024

This workshop built on three prior workshops held by the FDA-AACR, which took place in 2015, 2016 and 2017. And I do think it’s really important to go as high up as we can safely, because there are issues that have already been mentioned – inter-tumor heterogeneity, issues of tumor penetration and [pharmacokinetics] PK.”

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Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. Dose optimization for oncology products has been an issue flagged for improvement even prior to the creation of OCE.

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The Premier Consulting Blog

APRIL 25, 2023

In silico population pharmacokinetic (popPK) and physiologically-based pharmacokinetic (PBPK) modeling can reduce or eliminate certain clinical studies, as was done with the 505(b)(2) approval of the long-acting injectable Aristada® (aripiprazole lauroxil). [8] 8] US Food and Drug Administration (FDA).

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The Pharma Data

NOVEMBER 9, 2020

The pharmacokinetic tail—will this be a significant risk for drug resistance? It also has a long pharmacokinetic. It is not yet understood if this long pharmacokinetic tail will have any significant effect on drug resistance. iii 2015 Guideline on when to start antiretroviral therapy and on pre-exposure prophylaxis for HIV.

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Metabolite Tales Blog

JANUARY 22, 2025

Clinical pharmacokinetics and pharmacodynamics of the endothelin receptor antagonist macitentan. Clin Pharmacokinet. 2015 May;54(5):457-71. Other useful reading at: [link] [link] [link] References [1] Center for Drug Evaluation and Research Application Number: 217686Orig1s000 Integrated Review. doi: 10.1007/s40262-015-0255-5.

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New Drug Approvals

APRIL 5, 2025

11] [12] [13] The US Food and Drug Administration granted orphan drug designation to treosulfan in 1994, for the treatment of ovarian cancer; [14] and in 2015, for conditioning treatment prior to hematopoietic stem cell transplantation in malignant and non-malignant diseases in adults and pediatric patients. [15] 8 April 2015.

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Drug Target Review

JANUARY 20, 2025

Pharmacologically-guided dosing : Integrating pharmacokinetics (PK), pharmacodynamics (PD), and translational biomarkers into dose selection tailors drug administration regimens that maximize the therapeutic index of a drug. This approach underlies the identification of the OBD, backed by both clinical efficacy and drug tolerability data.

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