Common Sense for Drug Policy Blog

OCTOBER 29, 2024

The only studies reported in the FDA package inserts for both products are pharmacokinetic studies in healthy volunteers, which demonstrated substantially higher naloxone plasma levels than standard doses of naloxone (0.4 Int J Drug Policy. mg IM vs. 8 mg IN and 2 mg IM vs. 5 mg IM, respectively). In 2023, the FDA approved a 2.7

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Alta Sciences

JULY 3, 2025

MENU logo-altasciences EN - Main navigation Proactive Drug Development Solutions Compare Us Facilities About Us Resource Center Careers News & Events 30th Anniversary Celebration Contact Us Participate in a study Français Home Current: Business Leaders Review - The Heart and Strategy Behind Altasciences' Marketing Evolution Business Leaders (..)

Marketing 40

Marketing Pharmacokinetics Testimonials Biosimilars 40

New Drug Approvals

JULY 18, 2025

D-ARABINOFURANOSYL)- 4′-C-Azido-2′-deoxy-2′-fluoro-b-D-arabinocytidine Azvudine is an antiviral drug which acts as a reverse transcriptase inhibitor. [3] In addition to its antiviral activity, concentration of the drug in the thymus has suggested immune-targeting activity; this dual function is unique among RdRp inhibitors.8

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New Drug Approvals

JULY 21, 2025

Drugs 2021, 81, 1581−1585. (47) Safety, pharmacokinetics and pharmacodynamics of hetrombopag olamine, a novel TPO-R agonist, in healthy individuals. The crude product was triturated withethylacetatetorapidlyprovidehetrombopagfreebasein 97.5%yield.TreatmentwithethanolamineinTHFandEtOH 52,53 5,6,7,8-Tetrahydronaphthalen-2-yl amine (6.6)was

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The ChEMBL-og

DECEMBER 13, 2023

Assays des cribe the experimental set-up when testing the activity of drug-like compounds against biological targets; they provide useful context for researchers interested in drug-target relationships. On the other hand, the drug concentration and route of administration are more relevant for the interpretation of ADMET assays.

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Pharmacokinetics Drugs Drug Development Science 126

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term.

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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. Pharmacology A typical IND-enabling package includes information on the primary, secondary, and safety pharmacology of the drug.

Packaging 52

Packaging Pharmacokinetics Small Molecule Clinical Trials 52

Practical Cheminformatics

JANUARY 8, 2024

Picking up where we left off in Part I , this post covers several other ML in drug discovery topics that interested me in 2023. Most of the LLM activity in the drug discovery space in 2023 was reported as preprints from academic groups. Most of the drug discovery examples were underwhelming. Here’s the structure of Part II.

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Drugs Small Molecule Bioinformatics Packaging 136

The Premier Consulting Blog

JULY 31, 2024

In this blog, we explain the role of clinical pharmacology in drug development and demonstrate how the right strategy can accelerate development under the US Food and Drug Administration (FDA) 505(b)(1) and 505(b)(2) New Drug Application (NDA) pathways.

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PPD

JULY 29, 2024

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.

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Clinical Research Clinical Trials Research Trials 98

LifeSciVC

APRIL 24, 2024

Is a novel target at the inflection point where enough evidence is available to suggest it may prove to be a compelling drug? Directionality and Druggability: Does the proposed “direction” of insult and therapeutic intervention make sense, and can we drug our novel target with a compelling modality? based on “tool” molecule precedent.

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Production Small Molecule Regulations Trials 131

PerkinElmer

JANUARY 7, 2022

The pharmaceutical industry is under huge pressure to address the high attrition rates in drug development. There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. When imaged, the hiPSC showed a stable beating rate.

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Drugs FDA Approval Pharmacokinetics Drug Development 52

Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4.

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Small Molecule FDA Approval FDA Drugs 52

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. Read the fact sheet. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here.

Science 52

Science Clinical Trials Pharmacokinetics Pharmacy 52

The Premier Consulting Blog

AUGUST 8, 2024

On July 31, 2024, the US Food and Drug Administration (FDA) announced Fiscal Year 2025 (FY2025) Prescription Drug User Fee Amendments of 2022 (PDUFA VII) fee rates for the review of human drug and biological product applications along with prescription drug program fees.

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Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. Metabolites found in humans are also observed in monkeys, and all metabolites were found to possess <10% of the activity of the parent drug. of the administered radiolabel in the human ADME study.

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Small Molecule FDA Approval FDA Pharmacokinetics 59

Alta Sciences

OCTOBER 15, 2024

Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies. As my experience in preclinical research grew, so did my curiosity in the overall drug development process; I wanted to expand into clinical research. Image blog-thumbnail-up-close-jason_1.jpg

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Pharmacokinetics Drug Development Clinical Trials Science 52

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to. Since there was no change in drug substance, the sponsor was able to reference the DMF.

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Drugs Clinical Pharmacology Packaging Small Molecule 52

The Premier Consulting Blog

APRIL 15, 2024

By William Salminen , Madelyn Huang, & Andrew Emanuel Without concrete guidelines, it can be confusing when determining what nonclinical studies are needed for a Pre-Investigational New Drug application (PIND) meeting. In this blog, we will go into more detail about the unwritten nonclinical requirements for the PIND meeting.

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Metabolite Tales Blog

DECEMBER 13, 2023

N -glucuronidation: the human element By Julia Shanu-Wilson In our last blog of the year, we look at why N -glucuronidation of drugs is important in human drug metabolism. Glucuronidation is the most common phase II reaction observed in the metabolism of drugs in humans.

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Molecular Design

MARCH 26, 2024

With apologies to Manfred Eigen (1927 - 2019) I've just returned to Cheshire from the Caribbean and, to kick off blogging from 2024 I'll share a photo of the orchids at Berwick-on-Sea on the north coast of Trinidad. Overcoming these challenges will amplify the impact of structural biology on drug discovery.

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Drugs Pharmacokinetics Cell Based Assays Treatment 60

New Drug Approvals

DECEMBER 24, 2023

“Population pharmacokinetic/pharmacodynamic modelling of eplontersen, an antisense oligonucleotide in development for transthyretin amyloidosis” British Journal of Clinical Pharmacology. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S. Food and Drug Administration (FDA). Ionis Pharmaceuticals.

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Alta Sciences

SEPTEMBER 12, 2024

Each preclinical formulation development program has unique formulation goals; whether it be to maximize potency or bioavailability, to change the drug-release timing, to improve safety and stability, or to provide improved handling characteristics. We were required to develop a formulation from the ground up. Contact us today!

Pharmacokinetics 52

Pharmacokinetics Compliance Pharmaceuticals FDA 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 Contact us today to get started.

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Assay Development Pharmacokinetics Drug Development Drugs 52

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 Premier Consulting Blog

JANUARY 31, 2023

Food and Drug Administration (FDA) adopted an addendum to the guidance titled “ S1B(R1) Testing for Carcinogenicity of Pharmaceuticals ,” which had previously been finalized by the International Council for Harmonization (ICH). Pharmacokinetic and systemic exposure data is also important to consider. On November 1, 2022, the U.S.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

Since 1962, the FD&C Act has authorized FDA to require that sponsors of clinical trials submit data from “preclinical tests (including tests on animals)” in order to demonstrate that their drug is safe enough to advance to testing in humans. FDORA § 3209(a)(2). 42 U.S.C. § 262(k)(2)(A)(i)(I).

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Metabolite Tales Blog

FEBRUARY 16, 2024

This results in cleavage of the drug to two metabolites, M1 and M9, with only M1 retaining the 14C label. of total drug related material in plasma. Biotransformation studies which reveal significant cleavage of a drug could thus trigger a route involving dual radiolabelling. Eur J Drug Metab Pharmacokinet 48 , 411–425 (2023).

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Metabolite Tales Blog

MARCH 1, 2023

This mix of properties makes azoles very versatile in medicinal chemistry and each tend to have quirks of metabolism that we highlight in this blog. 4a Figure 4 CY3A4 mediated oxidation of baricitinib Indoles Indoles have the potential to be oxidised extensively by P450s with example indole-containing drugs are shown below.

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Metabolic Stability Drugs Pharmacokinetics Science 52

Molecular Design

JULY 18, 2020

Satchel Paige (1906-1982) The COVID Moonshot and OSC19 are examples of what are sometimes called crowdsourced or open source approaches to drug discovery. Open source drug discovery originated with OSDD in India and it should be noted that the approach has also been pioneered for malaria by OSM.

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New Drug Approvals

OCTOBER 24, 2023

3] [4] [5] [6] [7] [8] Society and culture Legal status Velsipity was approved by the US Food and Drug Administration (FDA) in October 2023. [1] Food and Drug Administration (FDA). “FDA Approves New Drug for Ulcerative Colitis” Medscape. 1] [9] [10] Names Etrasimod is the international nonproprietary name. [11]

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Metabolite Tales Blog

JANUARY 23, 2024

Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. This constitutes an interesting subset of 9 drugs, constituting over 25% of the new small molecule drug approvals in 2023!

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New Drug Approvals

JANUARY 13, 2023

6] Peak plasma concentrations of the drug are reached within one hour. [6] 8] There are no drug interactions identified with forasartan. [6] a comprehensive resource for ‘omics’ research on drugs” Nucleic Acids Research. The dose administered ranges between 150 mg-200 mg daily. [6] 1.44 (m, 4H), 1.58-1.75

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Pharmacokinetics Drugs Production Research 52

Common Sense for Drug Policy Blog

JUNE 24, 2024

The structure differs depending on the lipophilicity and steric expansion, which affects the pharmacokinetic aspects, but also the key interaction with monoamine transporters (MATs) in the central nervous system [ 112 , 113 ]. dwf_admin Mon, 06/24/2024 - 19:49 Source Kuropka, P., Zawadzki, M.

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Pharmacokinetics Drugs 52

New Drug Approvals

JANUARY 9, 2024

For drug development, it is typically advantageous to employ individual stereoisomers as they exhibit marked differences in pharmacodynamic, pharmacokinetic, and toxicological properties. Inhibitors of CDK7 are currently being developed for the treatment of cancer. mol) in THF (700mL) at -78 °C over a period of 30 min. 3.13 (m, 2H), 2.42-2.39

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The Premier Consulting Blog

APRIL 25, 2023

This act amends the Federal Food, Drug, and Cosmetic Act (FFDCA), which applies to new drugs, and the Public Health Service Act, which applies to biosimilars. In this blog post, we examine several alternative approaches to animal testing and how the FDA handles the application of these methods in specific scenarios.

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FDA Animal Testing Pharmacokinetics Pharmaceuticals 52

Alta Sciences

APRIL 11, 2025

Best Practices for Preclinical Dose Range Finding Studies pmjackson Fri, 04/11/2025 - 20:05 Dose range finding (DRF) studies are the foundation of preclinical drug development, providing crucial information on safety data to assist in the dose level selection before advancing into toxicology studies.

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