ASPET

AUGUST 21, 2024

ICH established S7B and E14 guidelines in 2005 to prevent drug-induced torsade de pointes (TdP), effectively preventing the development of high-risk drugs. This review details the onset mechanisms of drug-induced TdP, including I Kr inhibition, pharmacokinetic factors, autonomic regulation and reduced repolarization reserve.

Compliance 100

Compliance Pharmacokinetics Drugs Engineering 100

Alta Sciences

APRIL 17, 2024

We have significant expertise in analyzing pharmacokinetic, pharmacodynamic, and anti-drug antibody endpoints from the preclinical phase to clinical trials. ASO Resources Read this case study about resolving issues with matrix effect in ASO detection Read The Altascientist, “Antisense Oligonucleotides” 4.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

Metabolite Tales Blog

MARCH 1, 2023

2010, 75, 9, 3141–3143 [link] 22 Clin Pharmacokinet. 1994, 22, 659-662 [link] 18a Xenobiotica , 1986, 16, 11-20 [link] 18b Wood and Fibre Science. 2009, 41, 157-167 [link] 19 Molecules. 2020, 25, 4309 [link] 20 Drug Metab. 2013, 41, 508-517 [link] 21 J.

Metabolic Stability 52

Metabolic Stability Drugs Pharmacokinetics Science 52

Agency IQ

FEBRUARY 2, 2024

In 2005, the guidance was updated to include non-cytotoxic drugs were gaining in importance. The basic structure of the document hasn’t changed, and ranges from pharmacokinetics to exploratory studies, through to guidance on pivotal trials, safety, and more. For example, the first three editions focused on cytotoxic compounds.

Clinical Trials 40

Clinical Trials Trials Treatment Disease 40