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Formulation Development Study
Quote from Chief Pharmacist on October 6, 2024, 12:07 amAs a formulation development scientist you should have good understanding on below topics (but not limited to):
1. Polymorphism & solubility of API
2. Biopharmaceutics Classification
https://www.pharmaspecialists.com/2021/08/bcs-classification-of-dugs.html
3. Choice of excipients
https://www.pharmaspecialists.com/2023/01/choice-of-excipient-and-its-grade.html
4. API-Excipient compatibility study
https://pharmadigests.com/drug-excipient-compatibility-study-during-qbd/
5. RLD/RS characterization/Reverse engineering
https://www.pharmaspecialists.com/2021/11/pharmaceutical-rld-or-rs.html
6. FDA dissolution method database
https://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
7. FDA inactive ingredient database
https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
8. Dissolution profile
https://www.pharmaspecialists.com/2022/12/comparative-dissolution-profile.html
9. Stress/Force degradation study
https://www.pharmaspecialists.com/2022/07/forced-degradation-studies.html
10. Stability study
https://pharmadigests.com/stability-data-and-evaluation-of-finished-pharmaceutical-products/
11. Shelf- life Calculation
https://www.pharmacalculation.com/2023/01/shelf-life-calculation-of-drug-product.html
12. Impurities & Residual solvents
https://www.ema.europa.eu/en/ich-q3b-r2-impurities-new-drug-products-scientific-guideline
https://www.ema.europa.eu/en/ich-q3c-r9-residual-solvents-scientific-guideline
13. QbD tools & DoE
https://pharmadigests.com/pharmaceutical-quality-by-design-tools/
https://pharmadigests.com/design-of-experiments-doe-in-drug-formulation-development/
14. Process optimization and validation
https://www.pharmaspecialists.com/2022/04/process-optimization-of-pharmaceutical-products.html
https://industrialpharmacist.com/2023/09/process-validation-in-pharmaceutical-industry/
15. BE study and strategy
https://www.pharmaspecialists.com/2024/06/bioequivalence-be-in-anda-filing.html
16. SUPAC Guidance
17. ANDA
https://www.pharmaspecialists.com/2022/01/generic-drug-approval-process.html
18. Patent & Exclusivity
19. 21 CFR Part 211
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
20. Tablet problem & remedies
https://www.pharmaspecialists.com/2022/08/common-tablet-defects-and-remedies.html
As a formulation development scientist you should have good understanding on below topics (but not limited to):
1. Polymorphism & solubility of API
2. Biopharmaceutics Classification
https://www.pharmaspecialists.com/2021/08/bcs-classification-of-dugs.html
3. Choice of excipients
https://www.pharmaspecialists.com/2023/01/choice-of-excipient-and-its-grade.html
4. API-Excipient compatibility study
https://pharmadigests.com/drug-excipient-compatibility-study-during-qbd/
5. RLD/RS characterization/Reverse engineering
https://www.pharmaspecialists.com/2021/11/pharmaceutical-rld-or-rs.html
6. FDA dissolution method database
https://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm
7. FDA inactive ingredient database
https://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
8. Dissolution profile
https://www.pharmaspecialists.com/2022/12/comparative-dissolution-profile.html
9. Stress/Force degradation study
https://www.pharmaspecialists.com/2022/07/forced-degradation-studies.html
10. Stability study
https://pharmadigests.com/stability-data-and-evaluation-of-finished-pharmaceutical-products/
11. Shelf- life Calculation
https://www.pharmacalculation.com/2023/01/shelf-life-calculation-of-drug-product.html
12. Impurities & Residual solvents
https://www.ema.europa.eu/en/ich-q3b-r2-impurities-new-drug-products-scientific-guideline
https://www.ema.europa.eu/en/ich-q3c-r9-residual-solvents-scientific-guideline
13. QbD tools & DoE
https://pharmadigests.com/pharmaceutical-quality-by-design-tools/
https://pharmadigests.com/design-of-experiments-doe-in-drug-formulation-development/
14. Process optimization and validation
https://www.pharmaspecialists.com/2022/04/process-optimization-of-pharmaceutical-products.html
https://industrialpharmacist.com/2023/09/process-validation-in-pharmaceutical-industry/
15. BE study and strategy
https://www.pharmaspecialists.com/2024/06/bioequivalence-be-in-anda-filing.html
16. SUPAC Guidance
17. ANDA
https://www.pharmaspecialists.com/2022/01/generic-drug-approval-process.html
18. Patent & Exclusivity
19. 21 CFR Part 211
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211
20. Tablet problem & remedies
https://www.pharmaspecialists.com/2022/08/common-tablet-defects-and-remedies.html