Broad Institute

JULY 17, 2024

Together, the tools estimate how a drug may impact diverse outcomes of interest to drug developers: general cellular health, pharmacokinetics, and heart and liver function. Seal used these FDA-curated lists as training data for two toxicity-predicting machine learning models: one for cardiotoxicity and one for liver injury.

Pharmacokinetics 124

Pharmacokinetics Molecular Biology Drugs FDA 124

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

Treatment 100

Treatment Pharmacokinetics Drugs Cell Biology 100

Agency IQ

DECEMBER 1, 2023

FDA’s guidance on developing products to prevent or treat Covid-19 Of the five guidance documents that received an extension, one addresses the development of drugs and biological products for Covid-19. On November 23, the FDA published a new, direct-to-final post-PHE version of the document.

FDA 40

FDA Clinical Trials Vaccine Trials 40

FDA Law Blog: Biosimilars

MAY 21, 2024

On Thursday, May 16, 2024 , the Attorney General issued a Notice of Proposed Rulemaking (“NPRM”) to initiate rulemaking proceedings to reschedule marijuana. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). 21 U.S.C. § Basis at 18; NPRM at 44,605.

Regulations 69

Regulations FDA Drugs Treatment 69

Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. The committee also made recommendations regarding pharmacokinetic and safety assessments.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

The ChEMBL-og

APRIL 16, 2024

Data set retrieved on 09/02/2024. For legacy AUC and Cmax records (< ChEMBL 34), pharmacokinetic parameters have been extracted from the assay descriptions using regular expression matching (RegEx). We are delighted to announce the release of ChEMBL 34, which includes a full update to drug and clinical candidate drug data.

Clinical Trials 108

Clinical Trials FDA Cell Based Assays Compound Screening 108