Clinical Pharmacology and Therapeutics This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT Liability
Clin Pharmacol Ther. 2024 May 2. doi: 10.1002/cpt.3284. Online ahead of print.ABSTRACTCardiac safety regulatory guidance for drug development has undergone several monumental shifts over the past decade as technological advancements, analysis models and study best practices have transformed this landscape. Once, clinical proarrhythmic risk assessment of a new chemical entity (NCE) was nearly exclusively evaluated in a dedicated thorough QT (TQT) study. However, since the introduction of the International Council for Harmonisation (ICH) E14/S7B Q&A 5.1 and 6.1 TQT substitutions, drug developers are offered an alternativ...
Source: Clinical Pharmacology and Therapeutics - May 3, 2024 Category: Drugs & Pharmacology Authors: Robert M Lester Caroline Engel Aernout D van Haarst Sabina Paglialunga Source Type: research

Palatability evaluation of orally disintegrating tablets using a visual analog scale in clinical trials
CONCLUSION: The VAS method for assessing ODT palatability provides accurate information and can contribute to the design and manufacture of patient-friendly pharmaceutical products.PMID:38699974 | DOI:10.5414/CP204477 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - May 3, 2024 Category: Drugs & Pharmacology Authors: Motoyasu Miura Seiki Kojima Shimako Tanaka Yasuharu Kashiwagura Noriyuki Namiki Shinya Uchida Source Type: research

Pegylated-interferon alpha (PEG-IFN α)-induced interstitial lung disease in a patient with chronic hepatitis B: A case report and literature review
CONCLUSION: Although rare, IFN-induced ILD can lead to decreased lung function, and sometimes become fatal despite intensive treatment. Most previously reported cases were with chronic hepatitis C, and most of the medication was in combination with ribavirin. IFN-induced ILD should be monitored during IFN therapy, and appropriate steroid is recommended in patients with progressive manifestations.PMID:38699975 | DOI:10.5414/CP204504 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - May 3, 2024 Category: Drugs & Pharmacology Authors: Minghui Shi Shiyao Wang Yanhong Ren Ling Zhao Min Liu Lulu Yang Ting Yang Source Type: research

Degree of serum LDL cholesterol reduction by simvastatin and ezetimibe is dependent on baseline LDL cholesterol concentration but not on baseline values and changes of cholesterol synthesis and absorption parameters
CONCLUSION: Under ezetimibe, simvastatin, and combination treatment, ΔLDL-C is predominantly dependent on the baseline LDL-C concentration. We hypothesize that the concentration gradient between serum LDL-C and hepatic cellular cholesterol determines the efficiency of serum LDL-C lowering. Combination treatment is the preferred treatment.PMID:38699976 | DOI:10.5414/CP204536 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - May 3, 2024 Category: Drugs & Pharmacology Authors: Dieter L ütjohann Frans Stellaard Source Type: research

Approval of Mycophenolate Mofetil for Prophylaxis of Organ Rejection in Pediatric Recipients of Heart or Liver Transplants: A Regulatory Perspective
Clin Pharmacol Ther. 2024 May 2. doi: 10.1002/cpt.3288. Online ahead of print.ABSTRACTOn June 6, 2022, the FDA expanded the indications for mycophenolate mofetil (MMF) to include the prophylaxis of organ rejection in combination with other immunosuppressants in pediatric recipients of allogeneic heart or liver transplants aged 3 months and older. The approved oral dosing regimen for these patients was a starting dose of 600 mg/m2 with titration up to a maximum of 900 mg/m2 twice daily. Data to support efficacy in pediatric patients were derived from established pharmacokinetic (PK) relationships across approved populations...
Source: Clinical Pharmacology and Therapeutics - May 2, 2024 Category: Drugs & Pharmacology Authors: Amer Al-Khouja Nadia Chaudhri Ergun Velidedeoglu Ozlem Belen Youwei Bi Suresh Doddapaneni Jianmeng Chen Source Type: research

Zibotentan Can Be Co-administered with Contraceptives Containing Ethinyl Estradiol and Levonorgestrel: A Pharmacokinetic Drug-Drug Interaction Study
In conclusion, contraception containing ethinyl estradiol/levonorgestrel is regarded possible under zibotentan-containing treatments. This expands choices for women of childbearing potential, supporting diversity in the ZENITH High Proteinuria trial.PMID:38686600 | DOI:10.1002/cpt.3280 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 30, 2024 Category: Drugs & Pharmacology Authors: Anne-Kristina Mercier Abigail K Kois Deeyen Karsanji Richard Baldry Filip Birve Maria Hedwall Oleksandr Molodetskyi Michael Gillen Source Type: research

Dose Optimization Informed by PBPK Modeling: State-of-the Art and Future
Clin Pharmacol Ther. 2024 Apr 30. doi: 10.1002/cpt.3289. Online ahead of print.ABSTRACTModel-informed drug development (MIDD) is a powerful quantitative approach that plays an integral role in drug development and regulatory review. While applied throughout the life cycle of the development of new drugs, a key application of MIDD is to inform clinical trial design including dose selection and optimization. To date, physiologically-based pharmacokinetic (PBPK) modeling, an established component of the MIDD toolkit, has mainly been used for assessment of drug-drug interactions (DDIs) and consequential dose adjustments in reg...
Source: Clinical Pharmacology and Therapeutics - April 30, 2024 Category: Drugs & Pharmacology Authors: Karen Rowland Yeo Eva Gil Bergland Yuan Chen Source Type: research

From Dose to Exposure: Shifting the Paradigm of Pediatric Clinical Pharmacology Research and Education
Clin Pharmacol Ther. 2024 Apr 30. doi: 10.1002/cpt.3281. Online ahead of print.NO ABSTRACTPMID:38686743 | DOI:10.1002/cpt.3281 (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - April 30, 2024 Category: Drugs & Pharmacology Authors: Ronaldo Morales Junior Victor Amajor Kelli Paice Kathryn E Kyler H Rhodes Hambrick Kathryn E Pavia Andrew S Haynes Felicia Gooden Gwendolyn M Pais Kevin J Downes Laura B Ramsey Jonathan Wagner Sonya Tang Girdwood Source Type: research

Optimal Treatment Based on Interferon No Longer Makes Clinical Cure of Chronic Hepatitis B Far Away: An Evidence-Based Review on Emerging Clinical Data
Clin Pharmacol Ther. 2024 Apr 30. doi: 10.1002/cpt.3287. Online ahead of print.ABSTRACTChronic hepatitis B (CHB) remains a major global public health problem. The functional cure is the ideal therapeutic target recommended by the latest guidelines, and pursuing a functional cure has become the key treatment end point of current therapy and for upcoming clinical trials. In this review, based on the latest published clinical research evidence, we analyzed the concept and connotation of clinical cures and elaborated on the benefits of clinical cures in detail. Secondly, we have summarized various potential treatment methods f...
Source: Clinical Pharmacology and Therapeutics - April 30, 2024 Category: Drugs & Pharmacology Authors: Yujing Li Fada Wang Jing Zhou Lanqing Li Chengrun Song Enqiang Chen Source Type: research