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Alta Sciences
JANUARY 23, 2024
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Alta Sciences
JANUARY 23, 2024
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Fierce BioTech
OCTOBER 26, 2023
Are Gaps in Your Clinical Pharmacology Program Jeopardizing Your Drug’s Approval? Eva Gil Berglund, PhD Justin Hay, PhD Paola Coppola, MSc Duration 60 Minutes Clinical pharmacology information comprises more than 50% of a drug label. Click here to login. Listing Image Certara-LogoListing-12052023.png
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thought leadership
SEPTEMBER 20, 2023
The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall somewhere between drugs and biologics and do not have the usually well-defined characteristics of either category.
BioPharma Drive: Drug Pricing
FEBRUARY 20, 2024
Why clinical pharmacology is critical to accelerating drug development, and how it can help drive value in a complex and rapidly evolving landscape.
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.
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
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.
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.
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.
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.
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 (..)
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.
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.
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.
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
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.
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. food effect, smoking, and drug-drug interactions) on drug exposure and response.
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.
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.
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.
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.
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.
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!
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.
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.
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.;
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.
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.
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.
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.
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.
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) (..)
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.
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.
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.
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.
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 (..)
The Pharma Data
OCTOBER 1, 2021
The research, which spans clinical, health economics and outcomes research, translational, clinical pharmacology and preclinical presentations, highlights the breadth and depth of the company’s data on deucravacitinib, a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor, also because the emerging dermatology pipeline.
Agency IQ
JULY 28, 2023
This proposal is an exciting example of how new approaches at the forefront of clinical pharmacology can be leveraged to address the problems being discussed in other forums (e.g., While the exact timeline to publication varies after OIRA clearance, AgencyIQ expects publication to occur this quarter, if not sooner.
The Pharma Data
NOVEMBER 9, 2020
He is also a current member of the Health Canada Scientific Advisory Committee on Pharmaceutical Sciences and Clinical Pharmacology and the Scientific Advisory Panel on Opioid Analgesic Abuse.
Agency IQ
SEPTEMBER 15, 2023
FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinical pharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.
Agency IQ
OCTOBER 20, 2023
Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.
Metabolite Tales Blog
JULY 5, 2023
[link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S).
Metabolite Tales Blog
JULY 5, 2023
[link] [9] PHARMACOLOGY/TOXICOLOGY NDA REVIEW AND EVALUATION. APPLICATION NUMBER: 208261Orig1s000 [link] [10] SUMMARY OF PRODUCT CHARACTERISTICS for Viekirax [link] [11] CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S).
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