ASPET

MAY 22, 2024

Our findings emphasize the importance of metformin dose selection based on pharmacokinetic parameters for pre-clinical pharmacological studies. Metformin was quantifiable in the CSF at 30 minutes but decreased over time, with concentrations lower than those in the brain across all doses.

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Alta Sciences

JANUARY 23, 2024

With close to a decade of experience in the healthcare and pharmaceutical sectors, including clinical pharmacology, James will apply his knowledge to oversee the day-to-day management of clinical operations at Altasciences’ 140-bed, Phase I clinical pharmacology unit in Kansas City. “It

Clinical Pharmacology 40

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Alta Sciences

OCTOBER 5, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Clinical Pharmacology 52

Clinical Pharmacology Compliance Drug Development Pharmaceuticals 52

Alta Sciences

OCTOBER 31, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies , including formulation, manufacturing, and analytical services.

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Laboratories Clinical Pharmacology Cell Based Assays Drug Development 52

Drug Target Review

AUGUST 7, 2024

However, making informed labelling decisions during preclinical stages is complex and requires expertise in a variety of areas, including clinical pharmacology, toxicology, regulatory affairs and medical writing. Precise labelling and artwork help prevent confusion and enhance overall patient safety.

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Cytel

OCTOBER 27, 2023

Written by Natalia Muehlemann, Vice President, Clinical Development; Martin Frenzel, Research Principal, Statistical Consulting; and Michael Fossler, Vice President, Clinical Pharmacology The importance of dose selection and early phase clinical trial design was on the scientific agenda of the ESMO (European Society of Medical Oncology) Congress, which (..)

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Clinical Trials Trials Clinical Pharmacology Clinical Development 64

Alta Sciences

OCTOBER 9, 2024

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Trials 40

Alta Sciences

FEBRUARY 8, 2024

Utilizing 10 state-of-the-art simulators available in-house at our Montréal clinical facility (with the capacity for more than 20), we are equipped to measure a range of studies; from impairment in cognition and comparing compounds to assessing the impact on new formulations have on impairment.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Clinical Development 52

Alta Sciences

MAY 28, 2024

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Clinical Pharmacology 40

Clinical Pharmacology Drug Development Science Clinical Research 40

The Pharma Data

MARCH 8, 2022

Dr. Gunther Hartmann from the Institute of Clinical Chemistry and Clinical Pharmacology at the University Hospital Bonn, in cooperation with other members of the cluster of excellence ImmunoSensation2 at the University of Bonn, have shown this in mice. Researchers led by Prof. Participating institutions and funding.

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The Premier Consulting Blog

JUNE 8, 2023

The goal is to minimize regulatory and execution risks through a well-defined clinical, clinical pharmacology, nonclinical, and CMC (chemistry, manufacturing, and controls) development plan and a time and cost analysis for market entry. This robust plan will form the foundation of your pre-IND meeting preparation and discussion.

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Clinical Pharmacology FDA Drug Development Clinical Trials 52

Alta Sciences

SEPTEMBER 22, 2023

You can expect a robust program suited to your unique needs to support your IND submission and minimize potential risks, so you can transition smoothly from preclinical to clinical pharmacology. cardiovascular and respiratory); and • safety pharmacology endpoints in general toxicity studies.

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Clinical Pharmacology Drugs International Pharmaceuticals 40

Alta Sciences

AUGUST 28, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Alta Sciences

DECEMBER 14, 2023

Adherence to harmonized pharmacy-specific SOPs based on cGMP principles at our three clinical pharmacology units. Regulatory Excellence - Licenses for Schedule I through IV drug substances. Exceptional inspection results from major regulators such as the FDA, HC, EMA, and MHRA.

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Alta Sciences

SEPTEMBER 20, 2023

About Altasciences Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services.

Virus 40

Virus Clinical Pharmacology Drugs FDA Approval 40

Conversations in Drug Development Trends

FEBRUARY 21, 2024

The on-site cGMP Phase 1 pharmacy must have radiolabel drug preparation experience A clinical pharmacology unit (CPU) must be licensed and experienced in handling radioactive investigational drugs in order to complete your AME study.

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Clinical Trials Pharmacy Clinical Pharmacology FDA 80

Drug Target Review

JULY 4, 2023

Translational and Clinical Pharmacology [Internet]. Clinical Pharmacology & Therapeutics. 2022 [cited 2023 Feb 10];30(2):71. Liao MZ, Lu D, Kågedal M, Miles D, Samineni D, Liu SN, et al. 2021 Jul 8;110(5):1216–30.

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Small Molecule Drugs Clinical Pharmacology Trials 145

Drug Target Review

MAY 7, 2024

About the author Dr Luke Piggott, Associate Principal Scientist, Debiopharm Luke Piggott possesses extensive experience in developing novel therapeutics, spanning from discovery to clinical trials. At Debiopharm, he has overseen both preclinical and clinical pharmacology of assets from phase I to III.

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Disease Clinical Trials Clinical Pharmacology Trials 59

FDA Law Blog: Drug Discovery

JULY 17, 2024

clinical pharmacology/biomarkers, animal models, real-world evidence and other externally controlled comparisons [e.g., In fact, at this Scientific Workshop, Frank called for the creation of an alternative effectiveness standard for ultra rare diseases that relies on all available scientifically valid evidence (e.g.,

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FDA Disease Clinical Pharmacology Science 105

The Pharma Data

AUGUST 28, 2020

Dr Matthias Liechti, a Professor of Clinical Pharmacology at the University of Basel and head of the research lab that will be working on the study, said: “The potential of MDMA-LSD is to create a psychological state that may have the benefits of both substances and have longer lasting effects than standalone psilocybin or LSD.

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Clinical Trials Trials Clinical Pharmacology Therapies 52

Drug Target Review

SEPTEMBER 5, 2024

I am a pharmacist by training and continued with a PhD in Clinical Pharmacology. However, my goal was all the time to work with drug development in the pharma industry, so I moved on and started that journey in 1992 when I took on a role as Clinical Research Manager at AstraHässle, a mid-size Swedish pharma company.

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Pharma Companies Licensing Licensing Disease 111

New Drug Approvals

SEPTEMBER 10, 2024

. “A phase 1 study to evaluate the safety, tolerability and pharmacokinetics of TAK-041 in healthy participants and patients with stable schizophrenia” British Journal of Clinical Pharmacology. 88 (8): 3872–3882. doi : 10.1111/bcp.15305. PMC 9544063. PMID 35277995. S2CID 247407736. Rabiner, Eugenii A.;

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Clinical Pharmacology Small Molecule Pharmacokinetics Pharmaceutical Companies 62

The Premier Consulting Blog

SEPTEMBER 11, 2024

From a clinical pharmacology perspective, the sponsors also needed to establish a scientific bridge for relying on the data contained in the product labeling of the LD. This nonclinical study required good manufacturing practice (GMP) drug product, sham product, and vehicle to qualify the novel excipient used to modify absorption.

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Drugs Packaging Clinical Pharmacology Small Molecule 52

Sygnature Discovery

JANUARY 13, 2022

He gained a PhD in Clinical Pharmacology from the University of Lyon and an MD from Université Paris Diderot (Paris VII), and has since spent more than 35 years in the pharmaceutical, biotech and medical sectors in Europe and North America.

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Clinical Pharmacology Pharmaceuticals Laboratories Drugs 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. 88 (12): 5389–5398. doi : 10.1111/bcp.15468. PMID 35869634. S2CID 250989659. ^ “Eplontersen: FDA-Approved Drugs” U.S.

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Clinical Trials FDA Clinical Pharmacology Pharmacokinetics 62

DrugBank

FEBRUARY 9, 2023

Read the paper Jörn Lötsch Biomedical scientist at the Goethe - University Frankfurt am Main, Germany Research Focus: Knowledge discovery by combining artificial and human intelligence for information reduction of biomedical data with a focus on data science, pain, and clinical pharmacology.

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Clinical Pharmacology Molecular Biology DNA Licensing 52

Eye on FDA

AUGUST 4, 2021

The most active of these committees with vacancies this year has been the Oncologic Drugs Advisory Committee. Also the vacancies on the Peripheral and Central Nervous System Drugs Advisory Committee largely reflect the protest of the FDA approval decision in Alzheimer’s.

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FDA Clinical Pharmacology FDA Approval Therapies 122

Eye on FDA

JANUARY 5, 2022

Here is where FDA currently has vacancies: Bone, Reproductive and Urologic Drugs Advisory Committee – 4 vacancies Gastrointestinal Drugs Advisory Committee – 1 vacancy Pharmaceutical Science and Clinical Pharmacology Advisory Committee – 4 vacancies Pharmaceutical Compounding Advisory Committee – 1 vacancy.

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FDA Clinical Pharmacology Vaccine Production 76

Alta Sciences

MAY 15, 2023

Integrated Clinical Sites Accelerate Timelines Well-suited and qualified clinical pharmacology units (CPUs) for early phase trials are getting more expensive to run due to the growing complexity of required clinical procedures, and the precision around participants to be recruited.

Drug Development 52

Drug Development Clinical Trials Compounding Pharmacies Laboratories 52

FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

The Guidance notes that extrapolation of data across species is challenging; however, in accord with Agency pronouncements elsewhere on this topic, the Guidance describes FDA’s limited experience with alternative assays to characterize neurodevelopmental toxicity while expressing a theoretical openness to such methods when feasible.

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Production FDA Therapies Clinical Pharmacology 64

The Pharma Data

FEBRUARY 15, 2022

Astellas and Seagen will also present updates from the broader enfortumab vedotin program in four posters at ASCO GU 2022, including: EV-302: A 2-arm, open-label, randomized controlled phase 3 trial of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated advanced urothelial carcinoma (aUC) (Trial in Progress) (..)

Clinical Pharmacology 52

Clinical Pharmacology Trials Treatment Therapies 52

The Premier Consulting Blog

NOVEMBER 4, 2023

Conclusion The goals of a pre-IND meeting always include minimizing regulatory and execution risks in a drug development program through well-defined clinical, clinical pharmacology, nonclinical, and CMC development plans.

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Clinical Pharmacology Production FDA Packaging 52

The Premier Consulting Blog

JUNE 18, 2023

Figure 1: Comparison of Clinical Trial Designs The Prelude to Applying In Silico Trials for Rare Diseases In silico clinical trials have been recognized by the FDA as useful tools in advancing personalized treatment and streamlining randomized controlled trials.

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Drug Development Disease Clinical Trials Drugs 52

The Pharma Data

NOVEMBER 1, 2020

Suhail’s initial industry experience was at Pfizer, where he spent 12 years, initially in Sandwich, UK and then at Global R&D Headquarters in Connecticut, USA.

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Clinical Pharmacology Small Molecule Clinical Research Science 52

The Pharma Data

NOVEMBER 8, 2020

With over 10,000 employees, and operations in China, the United States, and the United Kingdom, Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China. www.pharmaron.com.

Clinical Pharmacology 40

Clinical Pharmacology Laboratories Science Pharmaceuticals 40

The Pharma Data

MAY 2, 2022

Data from the completed studies of zuranolone in the LANDSCAPE and NEST clinical development programs, including data from the ongoing open-label SHORELINE Study in MDD, as well as data from the completed clinical pharmacology studies, will comprise the full submission package.

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Treatment Clinical Pharmacology Drugs Clinical Development 52

Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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