| Estudios de Seguridad
ESTUDIOS DE SEGURIDAD
Ensayos
In Vivo
Ensayos
In Vitro / Ex Vivo
CLAIMS
MICROBIOLOGICAL CONTROL
According to ISO 21149
According to Ph. Eur. (European Pharmacopoeia)
STABILITY TEST
Stability screening (15 days approx.)
Temperature cycling
Mechanical shock testing
Light stability testing
Accelerated stability studies (3/6/9 months)
Conditions:
40 °C / 75 % RH
Customer specific requirements
Parameters:
Organoleptic characteristics
Physico-chemical characteristics
Microbiological control
Period after opening (PAO) determination
Long term stability studies (real time)
Parameters:
Organoleptic characteristics
Physico-chemical characteristics
Microbiological control
Container–content compatibility studies
According to the packaging material
CHALLENGE TEST
Challenge test (PET- Preservative Efficacy Test):
- According to ISO 11930:2012
- According to European Pharmacopoeia (Ph. Eur.)
- According to United States Pharmacopoeia (USP)
COMPATIBILIDAD CUTÁNEA-PATCH TEST
- Patch Test: 24 or 48 hrs
- Panel size: 10, 20, 30 or 50 panelists
- All skin types or sensitive skin only
- Occlusive or semi-occlusive
- Measures primary irritation/inflammation potential
- Always Dermatologist supervised
- Strip-Patch Test
- Photo-Patch Test
HIPOALERGENICIDAD HRIPT (RIPT)
HRIPT (RIPT):
- 50 panelists (all skin types)
- 50 panelists (sensitive skin only)
- 100 panelists (all skin types)
- 150 panelists (all skin types)
- Always Dermatologist supervised
OPEN-TEST (ROAT – REPEATED OPEN APPLICATION TEST)
Panel size: 10/20/30/50 panelists
Application at Research Center:
- 1 application (1 unique application)
- 3 applications (application every other day)
- 5 applications (application on each consecutive day)
Medical supervisions:
- Dermatologist
- Ophthalmologist
- Odontologist
- Gynecologist
IN-USE (AT HOME) STUDIES
Duration of the study: 7/14/21/28 days
Panel size: 20/30/50 panelists
Panel type:
Mixed (All genders)
Women only
Men only
Babies and kids
Babies or kids only
Specific demographics (Women 18-25 only)
Specific ethnicity or multi-ethnic
Medical supervisions:
- Dermatologist
- Ophthalmologist
- Odontologist
- Gynecologist
CONSUMER STUDIES
Duration of the study: 7/14/21/28 days
Panel size: 50/100/150 panelists
Panel type:
Mixed (All genders)
Women only
Men only
Babies and kids
Babies or kids only
Specific demographics (Women 18-25 only)
Specific ethnicity or multi-ethnic
- Low/Mid/High end products
- All distribution channels (pharmacy, mass-market, etc.)
