Related Experiment Video

Updated: May 7, 2026

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation
17:28

Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation

Published on: June 17, 2015

The STEP (Safety and Toxicity of Excipients for Paediatrics) database: part 2 - the pilot version

Smita Salunke1, Barbara Brandys, George Giacoia

  • 1Department of Pharmaceutics and Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, London, United Kingdom.

International Journal of Pharmaceutics
|September 28, 2013
PubMed

Insights

The Safety and Toxicity of Excipients for Paediatrics (STEP) database consolidates scattered excipient safety data. This resource aids researchers in selecting appropriate excipients for pediatric drug formulations.

Area of Science:

  • Pharmaceutical Sciences
  • Toxicology
  • Drug Development

Background:

  • Excipient selection is crucial in pediatric formulation, as adult-approved excipients may pose risks to children.
  • Existing toxicity data for excipients is fragmented across various sources, hindering accessibility and usability.
  • A comprehensive and accessible resource is needed to manage and disseminate excipient safety information for pediatric use.

Purpose of the Study:

  • To present an update on the Safety and Toxicity of Excipients for Paediatrics (STEP) database.
  • To describe the architecture, data fields, and functionalities of the STEP database.
  • To highlight the unique dual search capability of the STEP database.

Main Methods:

  • Development of a user-designed database compiling safety and toxicity data of pharmaceutical excipients.
  • Inclusion of preclinical, clinical, regulatory information, and toxicological reviews from over 2000 references.
  • Implementation of a dual search functionality allowing users to search "FOR" and "BY" excipients.

Main Results:

  • The pilot STEP database currently contains data for 10 excipients, drawing from over 2000 references.
  • The database integrates scattered safety and toxicity information into a single, freely accessible source.
  • The unique search functionality enables bidirectional querying of excipient safety data.

Conclusions:

  • The STEP database serves as a valuable, centralized resource for managing and exchanging excipient safety information.
  • The database aims to support informed decision-making in pediatric formulation development.
  • Expansion of the STEP database is planned to increase its practical research utility.

Keywords:
ACToRADIAFSSAPSAcceptable Daily IntakeAdverse effectsAgence française de sécurité sanitaire des produits de santé (French Agency for the Safety of Health Products)Aggregated Computational Toxicology ResourceCASCCOHSCanadian Centre for Occupational Health and SafetyChemical Abstracts ServiceChemicalsChildrenDatabaseEFSAESISESNEEEuPFIEuropean Food Safety AuthorityEuropean Paediatric Formulation InitiativeEuropean Study of Neonatal Excipient ExposureEuropean chemical Substances Information SystemExcipientsFDAFood and Drug AdministrationGRASGenerally Regarded As SafeIPCSITIUPACInformation TechnologyInternational Programme on Chemical SafetyInternational Union of Pure And Applied ChemistryJECFAJoint FAO/WHO Expert Committee on Food AdditivesNLMNRCNTPNational Library of MedicineNational Research CouncilNational Toxicology Program databasePK/PDPharmacokinetics/PharmacodynamicsSTEPSafety and Toxicity of Excipients for PaediatricsSmPCSummary of Product CharacteristicsToxicityURLUS PFIUniform Resource LocatorUnited States Paediatric Formulation InitiativeWHOWorld Health Organization

More Related Videos

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment08:59

An Intestine/Liver Microphysiological System for Drug Pharmacokinetic and Toxicological Assessment

Published on: December 3, 2020

Related Concept Videos

Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses a challenge in...
Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
Preclinical Development: Overview01:28

Preclinical Development: Overview

Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
Dosage Regimens: Partial Pharmacokinetic Parameters01:01

Dosage Regimens: Partial Pharmacokinetic Parameters

It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
Pharmacokinetics in Pediatric Patients: Drug Distribution01:17

Pharmacokinetics in Pediatric Patients: Drug Distribution

Drug distribution in the pediatric population exhibits unique challenges and considerations due to the physiological differences between children, particularly neonates and infants, and adults. A crucial aspect of pediatric pharmacology is understanding how these differences impact the pharmacokinetics of various drugs, necessitating age-specific dosing strategies to ensure efficacy and safety.Neonates and infants have a higher total body water content, ~75%–90% of their body weight, compared...