Practical Cheminformatics

JANUARY 8, 2024

A 2004 paper by Vigers and Rizzi proposed a similar strategy for docking studies. In addition to optimizing potency against a target of interest, we must design selective compounds with optimal pharmacokinetic profiles and a host of other desirable properties. It should be noted that this isn’t a new idea. What’s old is new again.

Drugs 141

Drugs Small Molecule Bioinformatics Packaging 141

New Drug Approvals

JANUARY 9, 2024

1004-1014, 2004). For drug development, it is typically advantageous to employ individual stereoisomers as they exhibit marked differences in pharmacodynamic, pharmacokinetic, and toxicological properties. 2006 Mar 1; 20(5):601-12, 2006), in contrast with CDK9, which phosphorylates both Ser-2 and Ser-5 of the CTD heptad (Pinhero et al.,

Production 62

Production DNA RNA Regulations 62

The Pharma Data

JULY 23, 2021

Outside Japan, the antibody combination has been authorised for emergency use or temporary pandemic use in additional territories and regions, including in the European Union, United States, India, Switzerland and Canada.

Treatment 52

Treatment Virus Clinical Trials Pharmaceuticals 52

The Pharma Data

MARCH 5, 2021

of regulation 726/2004 provides a harmonized, EU-level opinion on the efficacy, quality, and safety of the antibodies. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. The CHMP scientific opinion under Article 5.3

Treatment 40

Treatment Hospitals Long-Term Care Facilities Therapies 40

Sygnature Discovery

NOVEMBER 29, 2023

The QN-302 Phase 1 clinical trial is a multi-site, open-label, dose-escalation and dose expansion, safety, pharmacodynamic and pharmacokinetic study of intravenous QN-302 in patients with advanced or metastatic solid tumors. A total of up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study.

Clinical Trials 52

Clinical Trials Treatment Trials Small Molecule 52

Agency IQ

FEBRUARY 12, 2024

Another guidance will focus on pharmacokinetics in pregnancy, likely replacing a 2004 guidance document that the FDA never finalized, while a guidance the creation of a “REMS Logic Model” framework is meant to “link program design with assessment” – something called for in the most recent PDUFA VII commitment letter.

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 40

Sygnature Discovery

NOVEMBER 29, 2023

The QN-302 Phase 1 clinical trial is a multi-site, open-label, dose-escalation and dose expansion, safety, pharmacodynamic and pharmacokinetic study of intravenous QN-302 in patients with advanced or metastatic solid tumors. A total of up to 36 patients will be enrolled in the dose escalation (Phase 1a) portion of the study.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40