Alta Sciences

FEBRUARY 19, 2025

Food and Drug Administration (FDA) issued two guidance documents outlining the necessary evaluations during the clinical development of oligonucleotide therapeutics: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics and Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics .

Drug Development 52

Drug Development Clinical Pharmacology Immune Response Drugs 52

Drug Target Review

APRIL 7, 2025

Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics. Clarke trained in medicineand immunology at University College London and has had a long-standing interest in the utilisation of biomarker strategies in early clinical development. Rodrigues AD. 113:9861002.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

Alta Sciences

OCTOBER 29, 2024

PBSS - San Francisco Bay—Clinical Pharmacology Studies on Hepatic and Renal Impairments for NDA Filing iianiro Tue, 10/29/2024 - 16:53 Image gettyimages-1330763893-640x640.jpg jpg Synopsis Foster City, CA URL [link] Event End Date Fri, 11/01/2024 - 12:00 Event Start Date Fri, 11/01/2024 - 12:00 Weight 1

Clinical Pharmacology 40

Clinical Pharmacology 40

Alta Sciences

NOVEMBER 13, 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 Laboratories Drug Development Pharmaceuticals 40

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.

Pharmacokinetics 100

Pharmacokinetics Metabolic Stability Clinical Pharmacology Disease 100

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.

Small Molecule 145

Small Molecule Drugs Clinical Pharmacology Trials 145

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 (..)

Clinical Trials 64

Clinical Trials Trials Clinical Pharmacology Clinical Development 64

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.

Laboratories 52

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.

Drug Development 59

Drug Development Clinical Pharmacology Clinical Trials Drugs 59

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

Clinical Pharmacology Clinical Trials Drug Development Clinical Research 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

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.

Clinical Pharmacology 52

Clinical Pharmacology FDA Drug Development Clinical Trials 52

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.,

FDA 105

FDA Disease Clinical Pharmacology Science 105

Alta Sciences

APRIL 10, 2025

Altasciences is a forward-thinking drug development solutions company providing pharmaceutical and biotechnology companies with a flexible approach to preclinical and clinical pharmacology studies.

Clinical Pharmacology 52

Clinical Pharmacology Drug Development Drugs Therapies 52

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.

Clinical Trials 80

Clinical Trials Pharmacy Clinical Pharmacology FDA 80

Alta Sciences

NOVEMBER 20, 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 Trials 40

Clinical Trials Trials Clinical Pharmacology Drug Development 40

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.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Therapies 52

Alta Sciences

JUNE 14, 2023

and Canada are near our clinical pharmacology units, ensuring seamless transitions and swift sample analysis. With our expertise in exploratory and GLP studies, we offer tailored panels for immunophenotyping and cellular activation. In addition, our labs in the U.S. Speak with one of our flow cytometry experts. jpg Weight 3

Clinical Pharmacology 40

Clinical Pharmacology Engineering 40

Conversations in Drug Development Trends

JANUARY 6, 2025

By integrating biomarker analysis into clinical trials, researchers can reduce costs, minimize trial durations, and improve the likelihood of delivering innovative therapies to patients more rapidly and effectively.

Clinical Trials 52

Clinical Trials Trials Drug Development Therapies 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

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

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.

Clinical Pharmacology 40

Clinical Pharmacology Drugs International Pharmaceuticals 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.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

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.

Clinical Pharmacology 52

Clinical Pharmacology Pharmaceuticals Laboratories Drugs 52

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

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.

Disease 59

Disease Clinical Trials Clinical Pharmacology Trials 59

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.

Clinical Trials 62

Clinical Trials FDA Clinical Pharmacology FDA Approval 62

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

The draft guidance includes FAQs covering topics from across disciplines: regulatory review; chemistry, manufacturing, and controls (CMC); nonclinical and pharmacology/toxicology (PT); clinical; and clinical pharmacology.

Therapies 59

Therapies FDA Production Disease 59

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.

Clinical Pharmacology 52

Clinical Pharmacology Molecular Biology DNA Licensing 52

Alta Sciences

JULY 25, 2024

jpg Synopsis Discover 10 more essential life science resources, including expert insights, tips, case studies, webinars, podcasts, posters, scientific publications, videos, and more, that you may have missed from us!

Science 52

Science Clinical Trials Clinical Pharmacology FDA 52

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.;

Clinical Pharmacology 62

Clinical Pharmacology Small Molecule Pharmacokinetics Pharmaceutical Companies 62

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 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.

Clinical Pharmacology 52

Clinical Pharmacology Small Molecule Clinical Research Science 52

Alta Sciences

OCTOBER 30, 2023

Find out what the key factors are when developing nonclinical cell and gene therapies, including expert approaches to vindicating complex challenges, making your studies more efficient, and maximizing translational opportunities to first-in-human (FIH) trials. Read or listen now.

Science 52

Science Clinical Trials Pharmacokinetics Clinical Pharmacology 52

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.

Drugs 52

Drugs Clinical Pharmacology Packaging Small Molecule 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.

Clinical Pharmacology 52

Clinical Pharmacology Production FDA Packaging 52