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.

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The Pharma Data

MARCH 13, 2021

Hereditary Angioedema (HAE), like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Interactions.

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Practical Cheminformatics

JANUARY 8, 2024

When given the prompt “Please estimate the binding affinity between the drug Afatinib and target EGFR”, GPT-4 suggested a docking study, which is definitely not a wise choice. These fingerprint bits then map to atom environments or bond paths, which often don’t correspond to widely accepted functional group definitions.

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The Pharma Data

APRIL 13, 2022

Takeda ( TSE:4502/NYSE:TAK ) today announced that the Phase 3 SHP643-301 study ( NCT04070326 ) evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO ® (lanadelumab) in patients 2 to <12 years of age is complete and has met its objectives. At Takeda we’re a married champion for the cases we serve.

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Treatment Pharmacokinetics Vaccine Production 52

The Pharma Data

APRIL 7, 2022

announced today that the companies have entered into a definitive agreement under which Pfizer will acquire ReViral, a privately held, clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing novel antiviral therapeutics that target respiratory syncytial virus (RSV). Pfizer Inc.

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The Pharma Data

AUGUST 21, 2020

We are also supporting the consortium’s preclinical safety and pharmacokinetics workstreams. I guess that’s the true definition of situational leadership. Novartis has agreed to contribute a carefully curated library of about 1300 small molecules with antiviral activity to the CARE project. These will be screened against SARS-CoV-2.

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Vial

MARCH 15, 2024

Examples of vendors include: Laboratories : CROs often collaborate with specialized laboratories for various purposes, such as sample analysis or pharmacokinetic studies, among others. These collaborations with external vendors are aimed at accessing specialized expertise, technologies, or resources that they may not have in-house.

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The Pharma Data

JULY 11, 2021

Hereditary Angioedema (HAE), like so many other rare diseases, is highly complex, and patients, their families and caregivers often undergo years of strain trying to understand their disease, get a definitive diagnosis and gain access to the medicines they need. At Takeda we are a committed champion for the patients we serve. Interactions.

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Treatment Pharmacokinetics Disease Production 52

Agency IQ

AUGUST 9, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. What does that mean: “Phase 3”?

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The Pharma Data

SEPTEMBER 26, 2021

The positive CHMP opinion was supported data from pharmacokinetic bridging studies comparing VUMERITY and TECFIDERA® (dimethyl fumarate) to determine bioequivalent exposure of monomethyl fumarate, the active metabolite, and relied partially on the well-established long-term safety and efficacy profile of TECFIDERA.

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Molecular Design

MARCH 26, 2024

I am not aware of any transporters that are definitely considered to be anti-targets from the safety perspective (I'm happy to be corrected on this point) and inhibition of efflux pumps is a recognized tactic (see T2021 and H2020 ) in drug discovery.] I disagree with this assertion.

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Agency IQ

SEPTEMBER 22, 2023

The Heckler case helped to refine the definition of “substantial evidence” in two important ways. In 1997, Congress passed the FDA Modernization Act (FDAMA) , which—among other reforms— updated the definition of “substantial evidence” to allow for additional types of evidence, or “confirmatory evidence.”

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Agency IQ

DECEMBER 1, 2023

While the previous version stated that patients with kidney or liver dysfunction should be enrolled as long as the pharmacokinetics (PK) for the drug in such patients is “adequately understood,” the new guidance is phrased to indicate that, moving forward, the PK in these patients should be understood.

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The Pharma Data

MARCH 17, 2021

The primary objective is invasive disease-free survival (IDFS) defined according to the Standard Definitions for Efficacy Endpoints (STEEP) criteria. Secondary objectives include distant relapse-free survival, overall survival, safety, pharmacokinetics and health outcomes.

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Agency IQ

SEPTEMBER 15, 2023

The committee also made recommendations regarding pharmacokinetic and safety assessments. When looking at several pharmacokinetic studies, the FDA found that the 10 mg oral dose of phenylephrine has a very low bioavailability of less than 1% and, subsequently, low systemic alpha-1 adrenergic activity.

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Agency IQ

JUNE 9, 2023

It also contains a definition of the term immunotoxicity— the unintended immunosuppression or stimulation (including hypersensitivity) —which was notably absent from the draft. The new version contains several new sections which were not in the 2020 draft, including one on risk assessment and another on “administrative considerations.”

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Agency IQ

JULY 26, 2024

This guidance uses the following definition for in-house reference material: “appropriately characterized material prepared in-house by the manufacturer from a representative lot(s) for the purpose of biological assay and physiochemical testing of subsequent lots” (see ICH Q6B). Back to the questions: Q2, reference materials.

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Agency IQ

MAY 17, 2024

It’s within these documents and several other relatively recent MAPPs and guidances that FDA has finally provided definitions and clear criteria for how reviewers evaluate and determine the status of Abbreviated New Drug Applications (ANDAs) – the application type FDA uses to review and approve generic drugs.

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The Pharma Data

OCTOBER 27, 2020

See definition of non-GAAP earnings, a non-GAAP financial measure, and a reconciliation of net income to non-GAAP earnings below. In October 2020 , we completed a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. . 1.

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Agency IQ

OCTOBER 20, 2023

Obese patients should be included, and pharmacokinetic (PK) parameters for study drugs should be determined prior to phase 3 in both normal-weight and obese patients. Studies should not have an upper age limit for participation, and comorbidities shouldn’t be used as exclusion criteria, barring safety concerns.

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Agency IQ

FEBRUARY 2, 2024

In its latest iteration, the soup-to-nuts guidance runs to 43 pages, including a section on definitions and abbreviations but excluding appendices. The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more.

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Agency IQ

DECEMBER 11, 2023

Just a few months ago, OCE Associate Director HARPREET SINGH noted , “I know definitely for older adults… there’s not enough work done.” The FDA’s efforts here build on many of the concepts put forth in OCE’s 2022 guidance on the inclusion of older adults in cancer clinical trials.

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FDA Law Blog: Biosimilars

MAY 21, 2024

The State of Current Scientific Knowledge Regarding Marijuana HHS found that marijuana’s pharmacokinetic profile varies depending on the route of administration. The proposed rescheduling would not apply to synthetically derived THC outside of the CSA definition of marijuana, which would remain in schedule I. Basis at 24.

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Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

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Agency IQ

FEBRUARY 15, 2024

CDRH FY2024 Guidance Agenda Clinical application Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma CBER Final By 12/31/24 CBER CY 2024 Guidance Agenda Blood Considerations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method CBER Draft (..)

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Agency IQ

JUNE 28, 2024

estimated prevalence of the condition of interest, any relevant pharmacokinetic or pharmacogenomic data, demographic factors) and how they intend to meet those goals, as well as operational and process factors such as how they should be submitted and how the “action plan” may be updated over time. representative population.

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The Premier Consulting Blog

FEBRUARY 11, 2025

Challenges and complexities Rare diseases, by definition, affect a small percentage of the population, making it challenging to recruit enough participants with which to generate statistically significant data. It also doesnt help that the natural history of many rare diseases is not well understood.

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