Challenging the regulatory requirement for conventional acute toxicity studies in pharmaceutical drug development

Robinson, Sally; Ockert, Deborah; Stei, P.; Dreher, David; Somers, Kev; Donald, Elizabeth; Lampo, Ann; Kervyn, Sophie; Pickersgill, Nigel; Nogués, Vicente; Nahas, Kamil; Festag, Mathias; Brunel, P.; Old, Sally; Stark, Claudia; Delongeas, Jean-Luc; Chapman, Kathryn

doi:10.1016/j.tox.2006.11.018

Cited by 4 publications

(4 citation statements)

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“…Objective of acute toxicity tests is to detect a dose producing major adverse effects and an assessment of the minimum dose causing lethality. 6 Calotropis gigantean (Linn.) R. Br.…”

Section: Introductionmentioning

confidence: 99%

Sub-Acute Toxicity Study of Calotropis gigantea Latex Extracts in Male Swiss Albino Mice

Sanyal¹,

Maity²,

Pradhan³

et al. 2016

Toxicol Forensic Med Open J

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“…Objective of acute toxicity tests is to detect a dose producing major adverse effects and an assessment of the minimum dose causing lethality. 6 Calotropis gigantean (Linn.) R. Br.…”

Section: Introductionmentioning

confidence: 99%

Sub-Acute Toxicity Study of Calotropis gigantea Latex Extracts in Male Swiss Albino Mice

Sanyal¹,

Maity²,

Pradhan³

et al. 2016

Toxicol Forensic Med Open J

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“…So it is significant to determine the safety of these remedies in order to support their use. Acute toxicity is an initial screening step, mandatory in the toxic assessment and evaluation of all biological compounds (Akhila et al, 2007) and it establishes the moderate lethal dose (LD 50 ) of biological compounds (Robinson et al, 2007). Acute toxicity is usually defined as the variations occurring instantly or a short time following a single administration of compound within 24 hrs (OECD, 2000).…”

Section: Discussion:-mentioning

confidence: 99%

Safety Assessment of Partially Purified HDL Enhancing Phytocomponents From Desmodium Gyrans Dc.

Indu¹

2018

IJAR

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Ernakulam). A voucher specimen (SNMH-7012) was deposited in the herbarium of SNM College, Maliankara, Moothakunnam, Ernakulam. Collected aerial parts of plant were cleaned, dried under shade and powdered. The crude aqueous alcohol extract was prepared using 70% methanol in soxhlet apparatus. The extract was filtered and dried by evaporation. The solvent free DGM (1g) was loaded on to silica gel (60 x120 mesh) column (120 x 30 mm) based on polarity. The fraction eluted with distilled water was collected and evaporated to dryness and the solvent free residue (DGMAF) was used for the present study. This fraction (DGMAF) was dissolved in distilled water to a known volume. Animals were administered 5 g/kg b.wt for acute toxicity study, 100, 250 and 500 mg/kg b.wt for sub-acute toxicity study through oral route.

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“…Determination of acute oral toxicity is usually an initial screening step in the assessment and evaluation of the toxic characteristics of all compounds [9]. The present study focuses on the acute toxicity studies, which identify a dose causing major adverse effects and an estimation of the minimum dose causing lethality [10].…”

Section: Introductionmentioning

confidence: 99%

Acute and Repeated Oral Toxicity of Antidiabetic Polyherbal Formulation Flax Seed, Fenugreek and Jamun Seeds in Wistar Albino Rat

R¹,

BR²

2016

J Diabetes Metab

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Polyherbal formulations treating for various diseases bring attention to the human society. The toxicity and its safe dosage should be studied for dose optimization and formulation. The aim of this study was to evaluate acute and repeated oral toxic effect of the hydroalcoholic extract of polyherbal formulation such as flax seed, fenugreek and jamun seed (FFJ) on wistar albino rats. Acute toxicity was tested by single oral stepwise administration of the drug at the dose of 300 mg, 2000 mg and 5000 mg/kg bw. The toxicity and mortality were observed for every 30 minutes for first 24 hours and then day by day for 14 days. At the 29th day, the blood was collected by Sino orbital puncture for analysis of hematological and biochemical parameters. Then the animals were killed by cervical decapitation and organs were separated and weighed. The results showed that no toxic symptoms were observed up to the dose of 2000 mg/kgbw. But slight changes in the stool consistency, tremor, lethargy and sleep were observed at the dose of 5000 mg/kg bw. There is no significant change in the biochemical and liver enzymatic parameters of different treated groups of polyherbal formulations. The control group animals was observed as

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Challenging the regulatory requirement for conventional acute toxicity studies in pharmaceutical drug development

Cited by 4 publications

References 0 publications

Sub-Acute Toxicity Study of Calotropis gigantea Latex Extracts in Male Swiss Albino Mice

Sub-Acute Toxicity Study of Calotropis gigantea Latex Extracts in Male Swiss Albino Mice

Safety Assessment of Partially Purified HDL Enhancing Phytocomponents From Desmodium Gyrans Dc.

Acute and Repeated Oral Toxicity of Antidiabetic Polyherbal Formulation Flax Seed, Fenugreek and Jamun Seeds in Wistar Albino Rat

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