Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC includes a print copy delivered by postal mail and on-line access to electronic PDF copies of your subscribed issues.

Evaluation of Dosage Form Information Provided in Pediatric Drug Trial Reports

Author(s):  Haase Mark R, Luedtke Sherry, Robles Janie, Parker Thomas, Leff Rich, Giacoia George

Issue:  Jan/Feb 2009 - Compounding for Pediatrics
View All Articles in Issue

Abstract:  This report is the first to replicate the earlier findings of Standing et al and validates the inadequacy of reporting of dosage forms used in pediatric drug trials. Journal authors should provide and journal editors should require adequate dosage form information for published reports of pediatric drug trials. We also recommend that compounding pharmacists provide detailed compounding instructions to assure that extemporaneously compounded formulations can be reliably reproduced, and that quality-control data be provided to support formulation stability. Until the problem of insuffi cient information is addressed, replication of many pediatric drug trials is impossible, calling into question their reliability and validity.

Related Keywords: Mark R. Haase, PharmD, BCPS, Sherry Luedtke, PharmD, Janie Robles, PharmD, Thomas Parker, PharmD, Rich Leff, PharmD, George Giacoia, MD, children, dosage forms, clinical drug trials, journals

Related Categories: PEDIATRICS, DOSAGE FORMS/DRUG CARRIERS, INFORMATION RESOURCES

Printer-Friendly Version




Download in electronic PDF format for $45

Related Articles from IJPC
Title (Click for Abstract / Details) Author Issue Page View/Buy
Evaluation of Dosage Form Information Provided in Pediatric Drug Trial Reports Haase Mark R, Luedtke Sherry, Robles Janie, Parker Thomas, Leff Rich, Giacoia George Jan/Feb 2009 14-18 Buy
Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula Hossain Mohammad Faisal, Levesque Dan, Frye John, Rashid Mamoon Jul/Aug 2020 322-326 Buy
Compounding for Diabetic Patients:An Interview with Paul Lofholm, PharmD Allen Loyd V Jr Nov/Dec 1997 381-385 Buy
Finding the Right Balance: A Nationwide Study of Student Pharmacist Exposure to and Perceptions of Nonsterile Compounding Fredrickson Mary E, Belcher Faith G, Del Vecchio Kamryn N, Galleher Miranda N, Jugo Leila S, Gothard M David, Pallotta Raneem H, Pallotta Victor A Jr May/Jun 2022 242-247 Buy
Need for Appropriate Formulations for Children: The National Institute of Child Health and Human Development--Pediatric Formulations Initiative, Part 2 Giacoia George P, Taylor-Zapata Perdita, Mattison Donald May/Jun 2007 220-225 Buy
Stability Studies of Fludrocortisone Acetate Capsules and Fludrocortisone Acetate Titrated Powders (Powder Triturates) Brandin Thibaut, Wasilewski Maya, Panuccio Camille, Bouguergour Cyrielle, Primas Nicolas, Lamy Edouard, Jean Christophe, Bertault-Peres Pierre, Rathelot Pascal, Curti Christophe, Vanelle Patrice Mar/Apr 2022 150-154 Buy
Development and Validation of a Stability-indicating High-performance Liquid Chromatographic Method for Quantification of Progesterone in Compounded Glycerinated Gelatin Troches Burrows Anna C, Yellepeddi Venkata Kashyap, Snyder Spencer, Wakefield Meagan, Jackson David, Huynh Johnny, Nguyen Khoa, Sayre Casey L Jul/Aug 2019 340-350 Buy
Safe Cytotoxic Drug Preparation Using a Closed-system Transfer Device: Technical and Practical Evaluation of a New Device (Vialshield/Texium) Comparatively to a Reference One (Phaseal) Garrigue Philippe, Montana Marc, Ventre Christophe, Savry Amadine, Gauthier-Villano Laurence, Pisano Pascale, Pourroy Bertrand Mar/Apr 2016 148-154 Buy
Efficacy and Clinical Value of Commonly Used Ingredients in Pain Management Compounds: A Literature Review Beshay Sarah M, Rivera Gerard, Balthasar Jan, Florea Naomi Jul/Aug 2015 295-300 Buy
Novel Approaches to Topical Psoriasis Therapy Koyama Gregory, Liu Jenny, Scaffidi Alyse, Khazraee Maryam, Epstein Benjamin Sep/Oct 2015 357-365 Buy