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. Read the blog. Watch the video. Read the fact sheet. Listen here. Watch it now. The Altascientist : Issue No.

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Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

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. Sci Rep 9, 18911 (2019). 2021 [cited 16 December 2021].

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Drugs FDA Approval Pharmacokinetics Drug Development 52

The Premier Consulting Blog

APRIL 15, 2024

In this blog, we will go into more detail about the unwritten nonclinical requirements for the PIND meeting. Make It Fit-For-Purpose There is no one-size-fits-all approach because the nonclinical program is intimately tied to the pharmacology (PD), PK, and toxicology of the individual drug and the intended IND-opening study.

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Metabolite Tales Blog

APRIL 10, 2024

It is proposed that the decreased clearance of the drug observed in patients may be due to depletion of GSH in this population [10]. The next blog will complete our commentary on metabolism of small molecule drugs approved in 2023. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development.

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Small Molecule FDA Approval FDA Pharmacokinetics 59

The Premier Consulting Blog

AUGUST 8, 2024

Typically, new drug development under the 505(b)(2) pathway requires less capital and time and has a higher success rate versus the 505(b)(1) pathway, where the Sponsor develops safety and effectiveness information from scratch. For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g.,

Drugs 52

Drugs Pharmacokinetics FDA Production 52

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. Image blog-thumbnail-bioanalytical-platform-selection_0.png

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Assay Development Pharmacokinetics Drug Development Drugs 52

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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Animal Testing Biosimilars Cell Based Assays Clinical Trials 64

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.” 2022;144(7):2905-2920.

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Fragment Screening Clinical Trials Vaccine Pharmacokinetics 52

The Premier Consulting Blog

SEPTEMBER 11, 2024

However, the use of this novel polymer posed several challenges related to: The number of qualification studies required , including large nonclinical safety and clinical evaluations due to the changes in the dosage regimen, RoA, pharmacokinetics (PK), and use of a novel polymer. Human factors.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 52

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.

Marketing 59

Marketing FDA Regulations Pharmacokinetics 59

Agency IQ

JULY 28, 2023

In a September 2022 blog post , Califf acknowledged the broad scope of the crisis, saying ,“The opioid crisis has evolved beyond prescription opioids into a broader drug overdose crisis, largely driven by illicit fentanyl and its analogs. Read the full AgencyIQ analysis here.

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New Drug Approvals

JANUARY 9, 2024

Inhibitors of CDK7 are currently being developed for the treatment of cancer. For drug development, it is typically advantageous to employ individual stereoisomers as they exhibit marked differences in pharmacodynamic, pharmacokinetic, and toxicological properties. mol) in THF (700mL) at -78 °C over a period of 30 min.

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Production DNA RNA Regulations 62

The Premier Consulting Blog

APRIL 25, 2023

Opinions regarding how the new act will impact the industry vary, with predictions ranging from everything remaining at the status quo to the end of animal testing for new drug development and approvals. In the end, time will tell how the FDA implements the changes into actual practice.

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FDA Animal Testing Pharmacokinetics Pharmaceuticals 52

FDA Law Blog: Drug Discovery

JULY 9, 2024

We’ve blogged about some of FDA’s efforts to increase diversity in clinical trials previously, and the Draft Guidance itself describes a variety of these efforts. Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease.

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The Premier Consulting Blog

FEBRUARY 11, 2025

Identifying a safe and effective dose for registrational trials is one of the most critical and complex aspects of early-stage drug development for rare diseases. Traditionally, early drug development focuses on ensuring the safety of clinical doses, with regulatory authorities prioritizing patient protection.

Drug Development 52

Drug Development Disease FDA Drugs 52

The Premier Consulting Blog

DECEMBER 16, 2024

New drug development is a long and expensive process that can be fraught with obstacles, including unexpected delays, poor efficacy results, safety issues, or regulatory challenges. The need for difficult decisions The latest estimates on the median cost of bringing a new drug to market is now $2.3

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