Formal stability studies

Formal stability studies

Formal stability studies 

Phase I / Phase II Formal Stability Studies

As per the ICH Guidelines Q1A and Q1B, Tou Pharma Bio have provided the stability protocol design and testing for bulk drug substances and drug products.  The stability data has been generated by our Quality Control laboratory and appropriate reports for submission of the Chemistry, Manufacturing and Controls section of the Investigational New Drug (IND) application were prepared.  our controlled environmental and photostability chambers are alarm-monitored and connected to a backup power source, as required by ICH Guidelines Q1A; which are 40º C/75% RH, 30º C/65% RH, 25º C/60 % RH, 2-8º C, and -20º C. 

Tou Pharma Bio provides the following stability study activities.

• Protocol design according to ICH Guidelines
• Phase I and Phase II formal stability study testing according to ICH Guidelines
• Generation of data and preparation of reports appropriate for regulatory submission
• Accelerated and a real-time stability study testing
• Tou Pharma Bio provides stability studies of the following materials.
• Bulk drug substances and finished dosage forms
• Tou Pharma Bio has the ability to manufacture the following dosage forms for Phase I and Phase II clinical trials.

1. Capsules, hard gelatin or HPMC liquid-filled 
2. Capsules, hard gelatin or HPMC, powder-filled 
3. Capsules, controlled or sustained release 
4. Tablets, immediate release 
5. Tablets, controlled or sustained release 
6. Tablets, enteric coated 
7. Topical gels, creams, ointments 
8. Oral liquids 
9. Over-encapsulation