The Premier Consulting Blog

MAY 31, 2023

As a cornerstone of the drug development process, nonclinical investigational new drug (IND)-enabling studies are essential for supporting first-in-human (FIH) dosing for novel therapeutics. Secondary pharmacology evaluates the off-target effects of the drug on other receptors, ion channels, and enzymes.

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Drug Target Review

OCTOBER 3, 2024

In 2024 alone, almost 50 antibody drug candidates are anticipated to enter regulatory review, the majority of which are mAbs. Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 2018;10(4):539–46. Harth S, Frisch C. 2021;291–306.

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The Premier Consulting Blog

APRIL 15, 2024

We will use the term, nonclinical, to refer to any in vitro, ex vivo, or animal study conducted to support any stage of research and development of a new drug, such as proof-of-concept pharmacology studies through Good Laboratory Practice (GLP) toxicology studies. neurotoxicity) that require special assessments.

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Drug Target Review

SEPTEMBER 19, 2023

Some of the complex 3D models such as organoids and organ-on-chips have brought in realistic make-over to the drug screening and paved way into implementing high content screening, laboratory automation and miniaturisation in primary drug screening process. Microengineered physiological biomimicry: Organs-on-Chips.

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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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The Premier Consulting Blog

SEPTEMBER 11, 2024

The overall development strategy for GT123 was to include a complete CMC package. Since there was no change in drug substance, the sponsor was able to reference the DMF. However, the change in RoA required a single-species, one-month good laboratory practice (GLP) toxicology study. Human factors.

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Agency IQ

DECEMBER 1, 2023

Lastly, the revised guidance briefly discussed trials meant to assess drugs intended for prevention of Covid-19. For such studies, the FDA recommended a primary endpoint of laboratory-confirmed SARS-CoV-2 infection with or without symptoms. drug-drug interactions) and intrinsic factors (e.g.,

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The Pharma Data

AUGUST 30, 2021

Part B of the Phase 3 trial was informed by Part A , an open-label, single-ascending-dose, sequential cohort Phase 2 trial designed to assess the pharmacokinetics and safety of Dupixent in children aged 6 months to 5 years with uncontrolled severe atopic dermatitis.

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Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. Lykos responded to the outcome of the meeting in a press release.

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The Pharma Data

DECEMBER 5, 2020

Additionally, Regeneron bispecifics are manufactured using similar approaches used for human monoclonal antibody medicines, yielding similar properties and pharmacokinetics. REGN5458 and odronextamab are currently under clinical development, and their safety and efficacy have not been evaluated by any regulatory authority.

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Agency IQ

JUNE 9, 2023

BY RACHEL COE, MSC JUN 6, 2023 5:00 PM CDT What are nonclinical studies and when are they conducted in drug development? Good Laboratory Practice (GLP)-adherent toxicology studies (carcinogenicity, developmental and reproductive toxicology, etc.)

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Agency IQ

OCTOBER 20, 2023

In terms of general drug development considerations during the early phase, sponsors should consider obtaining Phase 1 data that demonstrate that the candidate drug has adequate penetration to the outer skin layers, after consultation with the agency about drug penetration study technique.

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Agency IQ

AUGUST 16, 2024

The final version newly clarifies that oncolytic viruses also fall outside the scope of the document and includes a new disclaimer that the guidance is not intended to address unique considerations of pediatric drug development. To be [administered with] food or not to be?

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FDA Law Blog: Drug Discovery

JULY 9, 2024

DAP Content In developing DAPs, the Draft Guidance recommends that sponsors consider whether certain demographic groups may have a different response to a medical product regarding either effectiveness or safety. providing language assistance); Reducing participant burden (e.g.,

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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

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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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.

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