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Phase I / Phase II Formal Stability Studies
IriSys provides stability protocol design and testing for
bulk drug substances and drug products according to ICH Guidelines
Q1A and Q1B. The Quality Control laboratory generates stability
data and prepares reports appropriate for submission of the Chemistry,
Manufacturing and Controls section of the Investigational New Drug
(IND) application. IriSys’ controlled environmental
and photostability chambers are alarm-monitored and connected to
a backup power source, as required. The environmental chambers
are controlled at conditions defined by ICH Guidelines Q1A; which
are 40º C/75% RH, 30º C/65% RH, 25º C/60 % RH,
2-8º C, and -20º C. IriSys provides the following
stability study activities.
- Protocol design according to ICH Guidelines
- Accelerated and real time stability study testing
- Phase I and Phase II formal stability study testing according
to ICH Guidelines
- Generation of data and preparation of reports appropriate for
regulatory submission
IriSys provides stability studies of the following
materials.
- Bulk drug substances
- Solid dosage form units
- Semi-solid dosage form units
- Oral liquid dosage form units
- Injectable dosage form units
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8810 Rehco Road, Suite F, San Diego, CA 92121
Tel (858) 623-1520 Fax (858) 623-1525 |
IriSys' formulation
development scientists and
cGMP manufacturing unit optimize the
formulation
of clinical trial materials. |
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