Drug Discovery World

JULY 25, 2023

Justin Hay , Senior Director, Amy Cheung Senior Director of Integrated Drug Development, and Patrick Loebs Director, at Certara, examine recent changes in paediatric guidelines and how they affect drug development projects. The section on ethics covers two examples of paediatric ethical factors to consider.

Drug Development 130

Drug Development Clinical Pharmacology Pharmacokinetics Drugs 130

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. Regulatory Excellence - Licenses for Schedule I through IV drug substances.

Compounding Pharmacies 40

Compounding Pharmacies Pharmacy Clinical Pharmacology Clinical Supply 40

Agency IQ

FEBRUARY 2, 2024

The documents describe all the guidance documents that are under development and that may be published in a given year. Medical device sterilization : Under a consent decree signed in August 2023, the Environmental Protection Agency (EPA) agreed to finalize its draft regulation on emission standards for ethylene oxide (EtO) by March 1, 2024.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

MARCH 1, 2024

12/29/2023 FDORA, Section 2512 Shortages : FDA must review its policies related to drug or biologic expiration dates and issue draft guidance or revise existing guidance on stability testing data in drug and biological product submissions.

FDA 40

FDA Science Clinical Trials Regulations 40

The Premier Consulting Blog

JUNE 18, 2023

This has opened new opportunities in pharmaceutical drug development, such as the ability to evaluate large complex databases and to integrate information in useful ways. One exciting application of these technologies is the use of in silico trials in the development of novel therapies for rare diseases.

Drug Development 52

Drug Development Disease Clinical Trials Drugs 52

Alta Sciences

AUGUST 28, 2023

Altasciences Completes Successful Phase I Trial of Ischemix’ Novel Compound for Treatment of Traumatic Brain Injury (TBI) pmjackson Mon, 08/28/2023 - 14:04 Laval, Québec, August 30, 2023 – Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s is a privately held drug development company based in Grafton, MA.

Trials 40

Trials Treatment Clinical Pharmacology Pharmacokinetics 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40