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Overview

Tags

Digestive System Disorders

Skin and Musculoskeletal Diseases

Infectious Diseases

Small molecule drug

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Infectious Diseases	1

Top 5 Drug Type	Count

Small molecule drug	3

Top 5 Target	Count

RNA polymerase	1
50S subunit(50S ribosomal subunit)	1
50S subunit x RARs	1

Cleaning agents (CAs) are used in multipurpose facilities to control carryover contamination of active pharmaceutical ingredients (APIs) to scientifically justified limits. While this is often done with the PDE methodology used for API impurities, it is unclear if it is justifiable and necessary for cleaning agents, which generally represent a comparatively lower health risk. Comparing calculated oral PDE values for CA ingredients (CAIs) from four companies with PDEs of a selected number of small-molecule APIs showed that the toxicity of CAIs is several orders of magnitude lower. Furthermore, a critical review of the toxicity and everyday exposure to the general population of the main CAIs functional groups showed that the expected health risks are generally negligible. This is particularly true if the associated mode of actions cause local toxicity that is usually irrelevant at the concentration of potential residue carryover. This work points towards alternative approaches to the PDE concept to control CAIs' contamination and provides some guidance on grouping and identifying compounds with lower health risks based on exposure and mode of action reasoning. In addition, this work supports the concept that limit values should only be set for CAIs of toxicological concern.

01 Nov 2018·Regulatory Toxicology and PharmacologyQ4 · MEDICINE

Finding synergies for 3Rs – Toxicokinetics and read-across: Report from an EPAA partners' Forum

Q4 · MEDICINE

Article

Author: Sauer, Ursula G ; Monshouwer, Mario ; Schutte, Katrin ; Kumar, Vikas ; van Aerts, Leon ; Rowan, Timothy ; Irizar, Amaia ; Müller, Boris P ; Taalman, Rob ; Desaintes, Christian ; Birk, Barbara ; Gardner, Iain ; Paini, Alicia ; John, David ; Laroche, Charles ; Reid, Kirsty ; Hubesch, Bruno ; Benndorf, Paul ; Weissenhorn, Renate ; Sachana, Magdalini ; Aggarwal, Manoj ; Dal Negro, Gianni ; Lostia, Alfonso ; Crozier, Jonathan ; Bender, Hans ; Manou, Irene ; De Gaetano, Federica ; Stirling, Catrina

The European Partnership for Alternative Approaches to Animal Testing (EPAA) convened a Partners' Forum Toxicokinetics and Read-Across to provide an overview on research activities to develop in vitro toxicokinetics methods and physiologically-based kinetic (PBK) models and to find synergies to enhance use of toxicokinetic data to strengthen read-across. Currently, lacking toxicokinetic data often prevent the application of read-across. Preferably, toxicokinetic data should be generated using in vitro and in silico tools and anchored towards human relevance. In certain sectors, PBK modelling is being used for risk assessment, but less so in others. Specific activities were identified to facilitate the use of in vitro and in silico toxicokinetic data to support read-across: The collation of available tools indicating the parameters and applicability domains covered; endpoint-specific guidance on toxicokinetics parameters required for read-across; case studies exemplifying how toxicokinetic data help support read-across. Activities to enhance the scientific robustness of read-across include the further user-friendly combination of read-across tools and formal guidance by the authorities specifying the minimum information requirements to justify read-across for a given toxicity endpoint. The EPAA was invited to continue dissemination activities and to explore possibilities to collate a contemporaneous list of open toxicokinetics tools that assist risk assessment.

100 Deals associated with GlaxoSmithKline UK Ltd.

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100 Translational Medicine associated with GlaxoSmithKline UK Ltd.

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Pipeline

Pipeline Snapshot as of 05 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

1

2

Approved

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Erythromycin/Isotretinoin ( 50S subunit x RARs )	-	Approved
Benzoyl Peroxide/Clindamycin Phosphate ( 50S subunit )	Acne Vulgaris More	Approved
GSK3082 ( RNA polymerase )	Hepatitis C More	Preclinical