PPD

JULY 29, 2024

This blog presents examples that demonstrate how AI can be used throughout the drug development process, with a specific focus on patient enrollment. AI has the capability to analyze and forecast the pharmacokinetic (PK) profiles of drugs following their administration.

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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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Alta Sciences

OCTOBER 15, 2024

Jason started his career as a research assistant carrying out operational phases of drug metabolism and pharmacokinetic studies. Image blog-thumbnail-up-close-jason_1.jpg Keep your curiosity about life sciences fresh and keep learning about the drug development process! jpg Weight 1

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LifeSciVC

APRIL 24, 2024

Given pharmacology can be a topic of its own, a colleague in the Atlas portfolio, Haojing Rong, has helped author a companion pharmacology blog post – if of interest in double clicking on this topic, please stay tuned for tomorrow’s post! based on “tool” molecule precedent.

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Production Small Molecule Regulations Trials 117

Alta Sciences

SEPTEMBER 12, 2024

Their goal was to develop a robust formulation prototype at the maximum potency, for preclinical work, including efficacy, pharmacokinetics , and toxicology studies. Client Study Overview A client approached us with the need to get their API BSC Class II compound through the preclinical formulation development phase. Contact us today!

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Alta Sciences

AUGUST 21, 2023

Our solutions include standalone services or integrated programs, providing assay development and top-quality data for toxicokinetic (TK) , pharmacokinetic (PK), and pharmacodynamic (PD) determinations to support your nonclinical and clinical studies. Image blog-thumbnail-bioanalytical-platform-selection_0.png

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Assay Development Pharmacokinetics Drug Development Drugs 52

PerkinElmer

JANUARY 7, 2022

There are many reasons that promising drug candidates are discontinued, including poor pharmacokinetics, lack of clinical efficacy, and toxicity. Available from: [link] The post Improving Drug Safety Through Cardiotoxicity Assessment first appeared on PerkinElmer Blog. 2021 [cited 16 December 2021].

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Drugs FDA Approval Pharmacokinetics Drug Development 52

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. Eplontersen , sold under the brand name Wainua , is a medication used for the treatment of transthyretin-mediated amyloidosis. [1] PMC 10540057.

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Clinical Trials FDA Clinical Pharmacology FDA Approval 62

Metabolite Tales Blog

APRIL 4, 2023

In this follow-up blog, “Metabolism of 2022 FDA approved small molecule drugs part 2”, we dig into the other drugs in this set that are cleared by multiple CYPs, mixed phase mechanisms and through involvement of gut metabolism (see Table 1 at the end of this blog). Dermavant’s tapinarof is one such friend. Br J Pharmacol.

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Small Molecule FDA Approval FDA Drugs 52

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. 8(2):3640-3648; [link] [11] Pharmacokinetics of the Multi-kinase Inhibitor Pexidartinib: Mass Balance and Dose Proportionality. J Pharm Biomed Anal. Oncotarget.

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The Premier Consulting Blog

AUGUST 8, 2024

For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g., patients with renal, hepatic, or cardiovascular concerns).

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Drugs Pharmacokinetics FDA Production 52

The Premier Consulting Blog

JANUARY 31, 2023

This blog post will explain how the WoE approach is used in toxicology studies and how the S1B(R1) addendum could affect your nonclinical program. Pharmacokinetic and systemic exposure data is also important to consider. 1,2,3 Its appendix offers case studies on the application of WoE in determining the utility of 2-year rat studies.

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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 ].

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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. Conclusion The authors assert: In drug discovery, truth is a molecule that transforms the practice of medicine. [I

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Drugs Pharmacokinetics Cell Based Assays Treatment 60

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. 2010, 75, 9, 3141–3143 [link] 22 Clin Pharmacokinet. The arrangement of these gives the common name and different physical chemical properties (Table 1). 2013, 41, 508-517 [link] 21 J.

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Metabolic Stability Drugs Pharmacokinetics Science 52

Metabolite Tales Blog

FEBRUARY 16, 2024

Eur J Drug Metab Pharmacokinet 48 , 411–425 (2023). Papers (both open access) 1. Piel I, Engelen A, Lang D et al. Metabolism and Disposition of the Novel Oral Factor XIa Inhibitor Asundexian in Rats and in Humans. Cuyckens F, Hvenegaard MG, Cassidy KC et al. Recommendations on multiple label use in human ADME. Drug Metab. January 12, 2024.

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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.” Journal of the American Chemical Society.

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Fragment Screening Clinical Trials Vaccine Pharmacokinetics 52

New Drug Approvals

OCTOBER 24, 2023

AS ON DEC2021 3,491,869 VIEWS ON BLOG WORLDREACH AVAILABLEFOR YOUR ADVERTISEMENT join me on Linkedin Anthony Melvin Crasto Ph.D – India | LinkedIn join me on Researchgate RESEARCHGATE join me on Facebook Anthony Melvin Crasto Dr. | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.

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FDA FDA Approval International Pharmacokinetics 57

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.

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Molecular Design

JULY 18, 2020

A number of peptidomimetic Mpro inhibitors have been described in the literature and this blog post by Chris Southan may be of interest. Here’s a blog post by Pat Walters in which he examines the structure-activity relationships emerging for the fragment-derived inhibitors.

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New Drug Approvals

JANUARY 13, 2023

“SC-52458, an orally active angiotensin II-receptor antagonist: inhibition of blood pressure response to angiotensin II challenges and pharmacokinetics in normal volunteers” Journal of Cardiovascular Pharmacology. 1.44 (m, 4H), 1.58-1.75 7.77 (m, 5H), 8.33 (d, J=2 Hz, 1H); MS (FAB) m/e (rel intensity) 417 (100), 208 (30); HRMS.

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FDA Law Blog: Drug Discovery

FEBRUARY 2, 2023

42 U.S.C. § 262(k)(2)(A)(i)(I).

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Animal Testing Biosimilars Cell Based Assays Clinical Trials 64

Metabolite Tales Blog

JANUARY 23, 2024

Pharmacokinetics and Disposition of Momelotinib Revealed a Disproportionate Human Metabolite—Resolution for Clinical Development. Pharmacokinetics and Metabolism of Nirmatrelvir. Health Sci Rep. 6(10):e1610. link] [8] Patent EP3428168A1. link] [9] Patent EP1242061B1. link] [10] FDA prescribing information for gepirone.

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Small Molecule FDA Approval FDA Pharmacokinetics 52

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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FDA Law Blog: Drug Discovery

JANUARY 7, 2024

Additionally, this review excluded pharmacokinetic and animal studies. This review was limited to drugs with approved New Drug Applications (NDAs); biologics and vaccines were excluded. In that ten-year period, there were 67 drugs approved with a requirement to conduct a postmarketing pregnancy study, and 99 studies.

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Marketing FDA Regulations Pharmacokinetics 59

Alta Sciences

APRIL 17, 2024

In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings.

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Drug Development Treatment FDA Approval Drugs 52

Practical Cheminformatics

JANUARY 8, 2024

Gotta be SAFE: A New Framework for Molecular Design [link] A blog post by Edward Williams from Terray Therapeutics introduced Contrastive Optimization for Accelerated Therapeutic Inference (COATI). In this paper, the authors then used 1.1 billion SAFE embeddings to train a generative model they call SAFE-GPT.

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New Drug Approvals

JANUARY 31, 2024

citation needed ] The pharmacokinetic properties of obeldesivir and improved was first published by Chinese researchers in May 2022. Due to their different metabolic pathways, obeldesivir can be administered orally, whereas remdesivir must be administered intravenously for COVID-19 treatment. Hz, 1H), 2.56 (p, J = 7.0

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RNA Science Treatment Pharmacokinetics 52

Codon

APRIL 2, 2023

Read Safety and pharmacokinetics of escalating doses of neutralising monoclonal antibody CAP256V2LS administered with and without VRC07-523LS in HIV-negative women in South Africa (CAPRISA 012B): a phase 1, dose-escalation, randomised controlled trial. Ricciardi M.J. Science Translational Medicine. ” Fierce Biotech.

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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

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. In this way, a program can potentially be reduced to a single-species carcinogenicity study, or animal testing may be waived altogether. [7]

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FDA Animal Testing Pharmacokinetics Pharmaceuticals 52

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. Basis at 18; NPRM at 44,605. Basis at 24.

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Regulations FDA Drugs Treatment 69

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. The deadline for the Draft Guidance was December 29, 2023, so the draft, issued on June 26, 2024, is about 6 months late under FDORA’s mandate.

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Metabolite Tales Blog

NOVEMBER 13, 2024

Our paper pick this month and latest blog describes the routes of biotransformation of Cytokinetics’ aficamten, a drug mainly eliminated by metabolism [1,2]. References [1] Pharmacokinetics, disposition, and biotransformation of the cardiac myosin inhibitor aficamten in humans. Drug Metab Pharmacokinet. Pharmacol Res Perspect.

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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 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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Metabolite Tales Blog

FEBRUARY 20, 2025

European journal of drug metabolism and pharmacokinetics, 50(1), 91103. Mass Balance Recovery, Absorption, Metabolism, and Excretion of Elinzanetant in Healthy Human Volunteers and in vitro Biotransformation. link] The post Oxidative biotransformation of elinzanetant to 3 active metabolites appeared first on Hypha Discovery.

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Pharmacokinetics Treatment Drugs 52

Metabolite Tales Blog

JANUARY 22, 2025

Clinical pharmacokinetics and pharmacodynamics of the endothelin receptor antagonist macitentan. Clin Pharmacokinet. Other useful reading at: [link] [link] [link] References [1] Center for Drug Evaluation and Research Application Number: 217686Orig1s000 Integrated Review. link] [2] Sidharta PN, Treiber A, Dingemanse J. Aprocitentan.

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