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Preformulation Study
How to conduct preformulation study for generic drug development?
In short, you can follow the below steps:
1. Check the regulatory approval status of the molecule (Like FDA, EMA, PMDA etc.).
2. When you find the regulatory approval status, download the reference pdf file (Like FDA Label, EMA Product Information, PMDA Review Report).
3. To check the compendial status you can search in BP/EP or USP. Where you will get the molecule structure, molecular weight, compendial requirements etc.
4. For approved drug product information you can visit:
- DailyMed for FDA Approved Molecules
- EMC for EMA Approved Molecules
Where you will get the qualitive formula, storage condition, packaging mode etc.
5. For API related information you can visit:
- PubChem
- DrugBank
Where you will get the molecule structure and physicochemical properties of the molecule.
6. For deep information you can find out:
- FDA Biopharmaceutics Review
- EMA Public Assessment Report
Where you will get the clinical study information, bcs class of the molecule, dissolution media etc.
7. For physicochemical characterization of the product collect the RLD from respective market.
Reference Articles:
1. Literature Review in Pharmaceutical Product Development
https://pharmadigests.com/literature-review-in-pharmaceutical-product-development/
2. RLD/RS Characterization
https://www.pharmaspecialists.com/2021/11/pharmaceutical-rld-or-rs.html
3. Quality by Design (QbD) in Pharmaceutical Industry
https://industrialpharmacist.com/2023/09/quality-by-design-qbd-in-pharmaceutical-industry/
Please share the development strategy for bcs class II & IV molecules.
