PPD

JUNE 20, 2023

Go deeper with our experts on rebadging advantages and best practices in this Applied Clinical Trials article. Does your CRO leverage data-backed intelligence to accelerate your clinical development strategy? Are your CRO’s services flexible and easily scaled to your needs?

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The Pharma Data

NOVEMBER 4, 2020

The article, entitled “Burden of Illness in Alopecia Areata: A Cross-Sectional Online Survey Study,” is available online at: [link]. Concert’s pipeline consists of clinical stage candidates targeting autoimmune and central nervous systems (CNS) disorders, and a number of preclinical compounds that it is currently assessing.

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Pharmaceuticals Clinical Trials Trials Treatment 52

The Pharma Data

MAY 7, 2021

Separately, the CHMP is also reviewing sotrovimab under Article 5(3) of Regulation 726/2004 and is expected to provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorisation. About the Sotrovimab Clinical Development Program.

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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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Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

SEPTEMBER 22, 2023

The guidance concludes with a brief section on “process considerations” that strongly emphasizes the importance of rationalizing the chosen approach to establishing efficacy with high specificity early in the clinical development process. When should this occur? at the end-of-phase 2 meeting).

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Agency IQ

JUNE 9, 2023

For this reason, animal models are still used both during drug discovery and the more intensive nonclinical studies conducted during clinical development. However, even the most innovative in vitro assays still present major limitations when it comes to fully understanding and assessing the risks of a product.

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FDA Science Small Molecule Immune Response 40

Agency IQ

JULY 26, 2024

Postapproval manufacturing changes for biological products During clinical development or following a product’s approval , sponsors and/or manufacturers may identify the need for a change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling.

Biosimilars 40

Biosimilars Science FDA Production 40

Agency IQ

DECEMBER 11, 2023

Progression-free survival (PFS) has been used for accelerated approval, traditional approval, and for measuring direct clinical benefits in certain circumstances. [ For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article.

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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.

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Agency IQ

AUGUST 16, 2024

Just a few months after the draft guidance on dose optimization was published, a handful of OCE staff, including its leaders, published a landmark article in March 2023. [Read the analysis of the comments submitted here] Since then, this topic has continued to be a priority for the FDA.

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Metabolite Tales Blog

NOVEMBER 13, 2024

Aficamten (CK-3773274) is a cardiac myosin inhibitor currently in phase 3 clinical development to treat this inherited disorder. References [1] Pharmacokinetics, disposition, and biotransformation of the cardiac myosin inhibitor aficamten in humans. Drug Metab Pharmacokinet. Drug Hunter article. 2024; 12:e70006.

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Pharmacokinetics Small Molecule Production Drugs 59

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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