Drug Patent Watch

DECEMBER 30, 2024

Key Requirements for Generic Drug Approval Bioequivalence Studies : The PMDA requires bioequivalence studies to ensure that the generic drug is equivalent to the RLD in terms of its pharmacokinetic and pharmacodynamic properties. Clinical Pharmacology & Therapeutics , 111(3), 531538. Pharmaceutical Regulations in Japan 2020.

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Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies 52

Drug Target Review

APRIL 7, 2025

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Clinical Pharmacology and Therapeutics. Clinical Pharmacology and Therapeutics. 21(10):3517.

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Clinical Development Clinical Trials Clinical Pharmacology Trials 69

New Drug Approvals

SEPTEMBER 10, 2024

. ^ Schiffer, Hans; Atienza, Josephine; Reichard, Holly; Mulligan, Victoria; Cilia, Jackie; Monenschein, Holger; Collia, Deanna; Ray, Jim; Kilpatrick, Gavin; Brice, Nicola; Carlton, Mark; Hitchcock, Steve; Corbett, Ged; Hodgson, Robert (18 May 2020). “S180. 46 (Supplement_1): S106–S107. doi : 10.1093/schbul/sbaa031.246. . ^

Clinical Pharmacology 62

Clinical Pharmacology Small Molecule Pharmacokinetics Pharmaceutical Companies 62

New Drug Approvals

APRIL 19, 2025

4] Landiolol can be used as first-line treatment for acute ventricular rate control in patients with atrial fibrillation (Level I recommendation- 2020 Guidelines of the European Society of Cardiology [15] ). Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. PMID 27092187. August 2000). 68 (2): 14350.

FDA 62

FDA Clinical Trials Treatment Trials 62

New Drug Approvals

SEPTEMBER 13, 2024

2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]

Treatment 62

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Agency IQ

SEPTEMBER 15, 2023

However, the Coronavirus Aid, Relief, and Economic Security (CARES) Act) of 2020 included provisions to overhaul OTC drug regulation. The committee also made recommendations regarding pharmacokinetic and safety assessments. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.

Science 40

Science FDA Clinical Trials Clinical Pharmacology 40

Agency IQ

JULY 28, 2023

During the COVID-19 pandemic, the number of opioid-involved deaths climbed sharply, with mortality rates increasing by 38% between 2019 and 2020. In 2020, the agency awarded a contract to “establish a COVID-19 Sub-Registry to collect data on the safety of drug products used for the prevention or treatment of COVID-19 infection.”

FDA 40

FDA Pharmacokinetics Clinical Pharmacology Government 40