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Explicit regulatory acceptance of minipigs for topical products

Minipig skin: basic biology and use in safety assessment

“Minipigs are especially useful for dermatological-related

evaluations...  36

“Value of minipig as a recommended second … species for regulatory studies to assess the risk, and relative efficacy of topical and systemic antifungals.” 2

Skin architecture, development and function in pigs and minipigs are well described. Minipigs and pigs are considered to have skin which most closely resembles human skin; a view shared by regulators.

the minipig has become a standard animal model in dermal toxicity studies submitted to the FDA…1

The basic structure of pig skin is well described5-7 as is the skin’s development from neonate to young adult8. Characteristics important to dermal toxicity testing, e.g. blood flow measurement, thickness at different ages, and permeation/penetration rates are published8-12, and it’s use in dermal toxicity testing, including phototoxicity13, 14, is extensively covered7, 15-19.

“… data lend increased support for the use of the minipig as an alternative predictive model for human IV and SC PK of mAbs.

Zheng et al., 2012.

Minipigs also have an impressive track record when it comes to case studies, i.e. marketed drug products where the minipig was used as non-rodent species; and overview can be found here1, and a detailed investigation of the minipig’s predictive value can be found here20.

20+ case studies of topical products approved using minipigs 

Ganderup, 2011.

Minipig as model of human skin diseases and conditions

Pigs and minipigs have been used to model many human dermal diseases and conditions. A non-exhaustive list includes: contact dermatitis/delayed-type sensitivity reactions21-26, dermal melanoma27-32, bullous pemphigoid33-35, radiation exposure16, 36-41, laser exposure42-47, and a genetically psoriasis model may well be under way48.

The entire nonrodent toxicology evaluation of a drug could be conducted in minipigs.3

A collection of dermal case studies where minipigs have been used

TRADE NAME PHARMACEUTICAL COMPANY INDICATION
Altabax, Altargo GlaxoSmithKline Impetigo
DUAC Topical Gel Stiefel Laboratories Inc. Acne
Dovobet Ointment Leo Pharma Psoriasis
Dovonex Leo Pharma Psoriasis
Clobex, Olux-E, Temovate E GlaxoWellcome Psoriasis
Vanos Medicis Pharmaceutical Corp. Psoriasis
Tazorac Allergan, Inc. Psoriasis, Acne, Lentigines
Tri-Luma Hill Dermaceuticals Melasma
Solagé Bristol-Myers Squibb Lentigines
Vaniga Bristol-Myers Squibb Hirsutism

The Rethink report

In the Rethink report the minipig is looked at as a tox species and the report confirms that the minipig is suitable as a non-rodent model as well as the dog and the non-human primate.   

Studies performed on minipigs are fully recognized by regulatory authorities worldwide and the use of the minipig is increasing.  

“We have reviewed the costs of testing in minipigs, and these are not significantly higher than the costs for a study in dogs. Economical reasons should therefore not be used to argue against the use of minipigs instead of dogs or monkeys.” 4 

Find the Rethink Report here 

 

See the extensive list of references that can provide you with further information about (mini)pigs in dermal toxicity studies.

 

You are welcome to contact us for further information or for a discussion about the use of minipigs in any type of study.