Novel Methods for the Assessment of Safety Pharmacology and Toxicology Parameters in Anesthetized and Ventilated Dogs Receiving Inhaled Drugs

Bujold, Kim; Pfeiffer, Juergen; Authier, Simon; Malcolmson, Richard; Fink, James B.; Tepper, Jeff

doi:10.1016/j.vascn.2019.05.151

Cited by 3 publications

(1 citation statement)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…There are various methods for the generation of test atmospheres which can involve a variety of different pieces of equipment and methodologies and can take some time to develop even by an experienced team. For more detailed information on this area, the reader is referred to in Teppler et al 16 and Bujold et al 17 Gases may be released from a pressurised cylinder via a regulator value and flow metre where it will be diluted by air to provide the required atmosphere. Vapours may be formed by evaporating a liquid in a stream of air driven by a syringe pump.…”

Section: Inhalation Deliverymentioning

confidence: 99%

A Review of the Main Considerations for Formulation Development in Preclinical Toxicology Studies

Saunders

2021

Int J Toxicol

View full text Add to dashboard Cite

The main considerations for the development of a formulation for preclinical safety assessment testing are explored. Intravenous, inhalation, oral and dermal dosing are given focus and although different dose routes do present their own individual challenges there are common themes that emerge. In each case it is necessary to maximise exposure to achieve high doses to satisfy regulatory requirements for safety assessment testing. This often involves producing formulations that are at the limits of solubility and maximum volumes possible for administration to different test species by the chosen route. It is concluded that for all routes it is important to thoroughly explore the stability of the test item in the proposed formulation matrix well ahead of dosing any animals, giving careful consideration to which excipients are used and what their underlying toxicity profile may be for the relevant preclinical species. In addition, determining the maximum achievable concentrations and weighing that against the maximum volumes that can be given by the chosen route in all the test species at an early stage will also give a read on whether it would be theoretically possible to achieve suitably high enough doses to support clinical work. Not doing so can cause delays in the development programme and may have ethical repercussions.

show abstract

Section: Inhalation Deliverymentioning

confidence: 99%