Microbial Efficacy & Analysis Program
Our Microbiological laboratory is modern and fully equipped to perform tests to....
              In-vitro
In-vitro Models are important as alternatives to animal & human testing and are key to efficacy & safety.....
Stability Study Management
We offer Stability Study Services to support all phases of Drug Development
Formulation Development
Stabicon understand the nature of healthcare business such that....
Stability Study Management

We offer Stability Study Services to support all phases of Drug Development



1. Pre clinical Stability study Management

  • These studies begin with preclinical phase to support animal toxicology.

2. Phase I stability study  Management

  • In Phase I, studies are used to establish drug/ excipient compatibility to assist in formulation development and ensure the stability of the API as formulated in the Clinical Trial Material (CTM).


3. Accelerated / stressed stability to support early specifications

  • Data from accelerated/stressed conditions provide important information that is used to support early specifications.


4. Phase II and Phase III stability study Management

  • These studies are conducted on the drug substance, and drug product and comparators during clinical trials.


5. Late Development  stability programs to support final specifications and shelf Life

  • These programs form the basis for understanding degradation kinetics and therefore provide scientific rational for the final specifications and shelf-life.


6. Registration Stability for NDA / MAA fillings

  • Most importantly, these studies are performed on manufacturing scale-up and/or process validation batches, and registration batches in final formulation and packaging for New Drug Application ( NDA / MAA ) fillings.


7. Marketed Product Stability to ensure commercial quality control

  • Phase IV, marketed product stability studies are conducted to ensure commercial Quality Control.


8. Stability studies to support scale-up and Post approval changes in existing process

  • Scale-Up and Post Approval Changes (SUPAC) and Product Life Cycle Management (PLCM) stability studies are used to support changes in the existing process and new dosage forms, delivery systems, and changes in packaging.




Stability Storage :


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Further Questions


If you have any queries regarding our services or would just like to discuss possibilities, Call +91 80 27839259/60 now to discuss your needs or email us at info@stabicon.com.

 

 

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