Clinical Pharmacology, Drugs and Pharmacy

Preparing the next generation of drug discovery scientists

Drug Discovery World

NOVEMBER 29, 2022

After just one cohort of students, the Clinical Pharmacology degree at St George’s University has been named the UK’s best pharmacology course. The curriculum and assessment structure is based on what the students will need to thrive in the drug development sector, with all scientific topics taught with the drug in mind first.

Clinical Pharmacology

Clinical Pharmacology Clinical Trials Drugs Drug Development

A Closer Look At Our On-Site Compounding Pharmacies

Alta Sciences

DECEMBER 14, 2023

A Closer Look At Our On-Site Compounding Pharmacies shajjar Thu, 12/14/2023 - 21:30 HTML Altasciences' dedicated pharmacists bring a wealth of expertise in controlled substances and complex compounding, ensuring maximum precision and safety standards. Electronic security access to the pharmacy and video monitoring. -

Compounding Pharmacies

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

Conversations in Drug Development Trends

FEBRUARY 21, 2024

Also known as a human radiolabeled mass balanced study, the AME study aims to determine the overall metabolism and excretion pathways of the NCE, as well as to identify and quantify circulating metabolites relative to parent or total drug-related exposure. To accomplish this, we pay careful attention to both dosing and sample collection.

Clinical Trials

Clinical Trials Pharmacy Clinical Pharmacology FDA

Top 10 Life Science Resources

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. Watch the video. Read the blog. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Listen here.

Science

Science Clinical Trials Pharmacokinetics Pharmacy

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year.

XPhyto Secures Exclusive Psychedelic Drug Development Agreement

The Pharma Data

NOVEMBER 9, 2020

Dr. Löbenberg holds Health Canada licences for research and analytical testing of a wide range of psychedelic compounds under the Controlled Drugs and Substance Act and research and analytical testing licences for cannabis under the Cannabis Act. . DMT (N,N-dimethyltryptamine). Prof. ” Prof. XPhyto Therapeutics Corp.

Drug Development

Drug Development Drugs Clinical Pharmacology Pharmaceuticals

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

SEPTEMBER 15, 2023

FDA’s nonprescription advisors find no efficacy for phenylephrine This week, FDA’s Nonprescription Drugs Advisory Committee (NDAC) voted unanimously that current scientific data do not support the efficacy of oral phenylephrine as a nasal decongestant, aligning with FDA analysis — and re-analysis — of data.

Science

Science FDA Clinical Trials Clinical Pharmacology

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

Many of those activities are tied to various user fee program commitments; a few others are related to other major pieces of legislation like last year’s Food and Drug Omnibus Reform Act (FDORA). We’re expecting to get a better sense in October about which of these bills might eventually start to move forward and potentially become law.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Agency IQ

OCTOBER 20, 2023

.” Interchangeable products can be substituted for the reference product at the pharmacy level, without prescriber intervention, within state and local regulations. The size of the trials was comparable to those of new molecular entities—drugs that have never before been approved by the FDA. million (IQR: $18-36.7 million). “We

Science

Science Biosimilars FDA Production

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

DECEMBER 11, 2023

By our count, the FDA’s Oncologic Drugs Advisory Committee held seven meetings in 2023; additionally, the Oncology Center of Excellence authored nine new (draft) and six final guidance documents. A key fact about the dostarlimab phase 2 trial for LARC: The drug was stunningly effective. months, according to the GSK presentation.

FDA

FDA Science Clinical Trials Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

OCTOBER 27, 2023

December has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may start the month of November with greater clarity about the FDA’s thinking about prescription drug importation plans.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

Perhaps the most important addition to FDA’s agenda is a proposed rule intended to clarify that Laboratory Developed Tests (LDTs) are to be regulated as medical devices under the Federal Food, Drug and Cosmetic Act (FD&C Act). Read our analysis of that rule here and here. ]

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

December also has a huge number of legislative deadlines associated with the Food and Drug Omnibus Reform Act of 2022. Drug Importation: We may soon receive greater clarity about the FDA’s thinking about prescription drug importation plans. December also typically brings end-of-year perspectives on the agency’s accomplishments.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

Priority A List.

FDA

FDA Science Biosimilars Production

Drug Discovery Digest

Preparing the next generation of drug discovery scientists

A Closer Look At Our On-Site Compounding Pharmacies

Trending Sources

Why Proactive AME Studies are Critical to Accelerating Your Approval Journey

TOP 5 WAYS INTEGRATED DRUG DEVELOPMENT SOLUTIONS SAVE YOU TIME AND MONEY

Top 10 Life Science Resources

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

XPhyto Secures Exclusive Psychedelic Drug Development Agreement

Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You BsUFA III regulatory science pilot offers progress report, fields stakeholder criticisms and questions

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

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