Bot Detector
IJPC Seal
Download FREE Sample Issue or Article
LEARN MORE
Subscribe Today
A subscription to IJPC provides on-line access to full-text, full-color, printable PDF copies of your subscribed issues, individual articles, and purchased archives.

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

Page(s):  14-18

Evaluation of Dosage Form Information Provided in Pediatric Drug Trial Reports Page 1
Evaluation of Dosage Form Information Provided in Pediatric Drug Trial Reports Page 2
Evaluation of Dosage Form Information Provided in Pediatric Drug Trial Reports Page 3
Evaluation of Dosage Form Information Provided in Pediatric Drug Trial Reports Page 4
Evaluation of Dosage Form Information Provided in Pediatric Drug Trial Reports Page 5

Download in electronic PDF format for $75

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



Related Articles from IJPC
Title/Author
(Click for Abstract / Details / Purchase)
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
Pg. 14-18

Incorporating Quality Assurance in Pharmaceutical Compounding-related Courses in the PharmD Curricula
Hossain Mohammad Faisal
, Levesque Dan, Frye John, Rashid Mamoon
Jul/Aug 2020
Pg. 322-326

Basics of Sterile Compounding: Biopharmaceutics of Injectable Dosage Forms
Akers Michael J
Jan/Feb 2017
Pg. 47-56

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
Pg. 148-154

Filling the Gaps on the Institute for Safe Medication Practices (ISMP) Do Not Crush List for Immediate-release Products
Uttaro Elizabeth
, Zhao Fang, Schweighardt Anne
Sep/Oct 2021
Pg. 364-371

Compounding for Diabetic Patients:An Interview with Paul Lofholm, PharmD
Allen Loyd V Jr
Nov/Dec 1997
Pg. 381-385

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
Pg. 340-350

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
Pg. 150-154

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
Pg. 242-247

Stability of Oral Liquid Dosage Forms of Ethacrynic Acid
Gupta Vishnu D
, Ling Jie
May/Jun 2001
Pg. 232-233

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
Pg. 220-225

Evaluation of the Most Frequently Prescribed Extemporaneously Compounded Veterinary Medications at a Large Independent Community Pharmacy
Karara Adel H
, Hines Ryan, Demir Zehra, Nnorom Bethran, Horsey Robert, Twigg Geoffrey
Nov/Dec 2016
Pg. 461-467

Basics: A Review: In Situ Gel Dosage Forms for Herbal Medicine Delivery
Rachmawati Putriana
Jan/Feb 2023
Pg. 24-29

Efficacy and Clinical Value of Commonly Used Ingredients in Pain Management Compounds: A Literature Review
Beshay Sarah M
, Rivera Gerard, Balthasar Jan, Florea Naomi
Mar/Apr 2024
Pg. 111-116

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
Pg. 295-300

Novel Approaches to Topical Psoriasis Therapy
Koyama Gregory
, Liu Jenny, Scaffidi Alyse, Khazraee Maryam, Epstein Benjamin
Sep/Oct 2015
Pg. 357-365

Formulation Development of Modafinil Sprinkle Dosage Form: Study on the Effect of Food on Dosage
Kumaravelrajan Rajagopal
, Karthik B, Venkatasan Suba
Nov/Dec 2022
Pg. 516-521

PreScription: A New Dosage Form
Allen Loyd V Jr
Sep/Oct 2022
Pg. 356

Microwave Freeze-thaw Technique for Injectable Drugs: A Review Updated from 1980 to 2021
Hecq Jean-Daniel
, Soumoy Laura, Closset Mélanie, Colsoul Marie-Lise, Jamart Jacques, Galanti Laurence
Nov/Dec 2021
Pg. 446-462

Efficacy and Clinical Value of Commonly Compounded Hormone Replacement Therapy: A Literature Review
Beshay Sarah M
, Rivera Gerard, Balthasar Jan, Florea Naomi
Jan/Feb 2015
Pg. 6-12

Return to Top