Fierce BioTech

MAY 1, 2024

Join us on Monday, June 19, 2024 for one hour all about oral cyclic peptide drug development. With “specialized for peptide” drug metabolism and pharmacokinetics (DMPK) and biological evaluation, we’re able to solve certain synthesis issues found across different cyclic peptides, complexes peptides and mimetic peptides.

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Drug Discovery World

JANUARY 23, 2023

“As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics. Additionally, the clinical trial period will be considerably shorter than that required for new drug development.

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Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

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Drug Discovery World

JUNE 29, 2023

Read more: FDA recommendations to inform psychedelic drug development Elevating extracellular serotonin In 2023, Evecxia Therapeutics reported favourable safety, tolerability, pharmacokinetic, and pharmacodynamic data from a Phase I trial of EVX-101 in healthy volunteers treated with escitalopram.

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Drug Discovery World

NOVEMBER 29, 2022

The new Clinical Pharmacology degree was launched in 2019 by Professors Emma Baker and Iain Greenwood and aims to take a holistic view of the development of drugs and create graduates that will stand out in the job market. Pharmacokinetics: How the body handles drugs.

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Alta Sciences

OCTOBER 30, 2023

Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Watch the video. Listen here. Watch it now. The Altascientist : Issue No.

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BMG Labtech

MARCH 11, 2024

In drug development and discovery, ELISAs are useful to quantify drug concentrations in biological samples where they find applications in studies of drug efficacy, pharmacokinetics, and pharmacodynamics. This type of application helps guide the development and optimization of therapeutics.

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Drug Discovery World

SEPTEMBER 26, 2022

In terms of the benefits drug repurposing can bring, Jackson says that if “done right, a drug developer has an opportunity to reduce overall drug development risk through some of these repurposing strategies.” . “In

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The Premier Consulting Blog

APRIL 15, 2024

For example, a new fixed dose combination product using two FDA-approved active pharmaceutical ingredients (APIs) may benefit from a preliminary drug-drug interaction (DDI) screen to rule out possible pharmacokinetic (PK) interactions and facilitate a more informed discussion with the FDA regarding the necessity of GLP combination toxicity studies.

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ASPET

JANUARY 31, 2024

The effects of BMS-986371, a potent in vitro inhibitor of BCRP ( IC 50 0.40 µM), on the pharmacokinetics of riboflavin, isobutyryl carnitine, and arginine were then examined in healthy male adults (N = 14 or 16) following oral administration of methotrexate (MTX) (7.5

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Drug Discovery World

OCTOBER 13, 2022

There was a selection of the technologies we will present including cell-based assays, ion indicator dyes, inhibitors, pharmacokinetic assays, bioisimilars, assay development antibodies, conjugation particles and other reagents for your drug discovery and development pipeline. .

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PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. With around 90% of candidates failing during clinical development, 1 the process is not only long and risky, but also expensive for those involved. References Hingorani, A.D., Sci Rep 9, 18911 (2019).

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DrugBank

MARCH 7, 2024

Moreover, smaller companies like Altimmune are seeking partnerships to propel the development of their experimental drugs. As larger players scout for innovative solutions, partnerships with smaller firms offer a pathway to accelerate drug development and diversify product portfolios.

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Alta Sciences

AUGUST 21, 2023

Efficient Characterization of ADME A critical feature of the bioanalytical platform selected for a drug development program is how well it characterizes the ADME (absorption, distribution, metabolism, excretion) of your molecule of interest. Why Partner With Altasciences for Your Bioanalytical Projects?

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

While this hype may be warranted in some respects—a 60-year old legal provision has now been amended to acknowledge that the science of drug development is advancing—the change is mostly symbolic and is likely to take many years before we see it have a measurable impact. 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. At Altasciences , we have extensive experience testing various pain models.

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PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The speed at which COVID-19 vaccines were developed was remarkable, but like most newly developed vaccines, there was variation among who could receive the shots and when.

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Drug Discovery World

APRIL 12, 2023

This paid-for advertorial by CN Bio appeared in DDW Volume 24 – Issue 2, Spring 2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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Drug Discovery World

JANUARY 20, 2023

This paid-for advertorial by CN Bio appeared in the SLAS 2023 Supplement, Volume 24 – Issue 1, Winter 2022/2023 Despite advancements, the drug development process remains inefficient. Existing in vivo and in vitro models aren’t up to the challenge Preclinical tools exist for the evaluation and screening of potential drug candidates.

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Drug Discovery World

AUGUST 22, 2023

For instance, the development team would have to perform a deep characterisation study to understand the goalpost and which formulation might be successful or which characteristics might influence the pharmacokinetic (PK) study while determining how the body handles the substance. Other significant challenges include: 1.

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Drug Target Review

OCTOBER 24, 2023

We also believe that drug development teams should routinely consider the potential modifying effect of the gut microbiome on drug potency and factor it into assessments of PK and PD.

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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

To better understand FDA’s approach in classifying postmarketing pregnancy studies as PMRs or PMCs, we reviewed all postmarketing requirements (PMRs) and postmarketing commitments (PMCs) related to maternal and fetal outcomes in FDA’s PMR/PMC database for drugs approved in the ten-year period from January 2014 through December 2023.

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Agency IQ

JULY 28, 2023

Physiologically-based pharmacokinetic (PBPK) models are defined by FDA as drug development tools that mathematically integrate physiological, physicochemical, and drug-dependent preclinical and clinical information to predict an investigational drug’s absorption, distribution, metabolism, excretion (ADME), and pharmacokinetics (PK).

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Agency IQ

DECEMBER 1, 2023

As before, the guidance provides recommendations on drug development for COVID-19 across five domains: population, trial design, efficacy endpoints, safety considerations and statistical considerations. drug-drug interactions) and intrinsic factors (e.g.,

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Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

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The Pharma Data

SEPTEMBER 7, 2021

Volunteers for the trial are being enrolled at Columbia University in New York City and Clinilabs Drug Development Corporation, based in Eatontown, New Jersey.

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Drug Discovery World

AUGUST 3, 2023

Dr Sodergren told DDW in an exclusive comment: “I am hopeful that over the next few years we will see further investments by governments and funding bodies to accelerate pre-clinical and clinical research programmes. At UC San Diego Health, there are currently eight cannabis clinical trials in progress 9.

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The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. The study will be conducted in South Africa. For more information, visit www.scynexis.com.

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PerkinElmer

JUNE 3, 2022

Writing in JACS , the researchers concluded: “Based on the broad-spectrum antiviral effect combined with promising selectivity and in vitro pharmacokinetic profile, the scaffold represented by [this compound] is one of the most promising for development of an antiviral drug targeting SARS-CoV-2.”

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The Pharma Data

NOVEMBER 5, 2021

With presently no approved treatments, there’s a major unmet need for curatives that can delay progression to order failure, “ said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis.

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Agency IQ

MAY 17, 2024

How have pre-submission meetings for generic drug applicants changed under GDUFA III? Under GDUFA III, the scope and purpose of pre-submission meetings for generic drug developers has changed. The generic drug user fee program is currently on its third iteration (i.e.,

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Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market. Image Social media_e-bulletin Ethnobridging.jpg Tags Clinical Trials Weight 1

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PPD

SEPTEMBER 19, 2023

During the drug development process, companies have a choice of different approaches based on their development plan requirements. Benefits of Early Drug Development Services Early development studies include many elements that set them apart from those in later development.

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Drug Target Review

JULY 12, 2023

The goal of DCI in preclinical and clinical assessments is to achieve a manyfold higher drug free-fraction pharmacokinetic (PK) C max level (the plasma concentration of therapy in a specific area of the body) to break tumour addiction to the MAPK signalling pathway followed by a rapid drop off of drug levels enabled by a short plasma half-life.

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The Pharma Data

DECEMBER 9, 2020

The open-label Phase 2a ‘AMBITION’ study is designed to assess safety, tolerability, pharmacokinetics and biomarker analyses for early assessments of efficacy of 75 mg and 225 mg CRV431, administered orally to F2 and F3 NASH patients (n=18/dosing group), once daily for 28 days.

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The Pharma Data

DECEMBER 28, 2020

The primary objectives of the AMBITION trial are to assess safety and tolerability of CRV431, as well as to delineate pharmacokinetics. In this study, which is being conducted at 10 U.S. sites, CRV431 is administered orally, once-daily for 28 days.

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Drug Discovery World

JANUARY 31, 2024

The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumoural activity of OT-A201. The study is a European multicentre and open-label study that will be conducted in two parts.

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