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Biowaiver monographs are literature reviews, in which publicly available data are gathered and organised to address the question of whether a biowaiver can be recommended for a new formulation of an active pharmaceutical ingredient (API). Parameters and points discussed are: solubility and permeability, dissolution of dosage forms, pharmacokinetics, the therapeutic use and therapeutic window of the API, data on excipient interactions and problems with bioavailability and/or bioequivalence.
1. Acetaminophen = Paracetamol 2. Acetazolamide 3. Acetylsalicylic acid 4. Aciclovir 5. Amitriptyline Hydrochloride 6. Amodiaquine Hydrochloride
7. Amoxicillin trihydrate 8. Atenolol 9. Bisoprolol fumarate 10. Chloroquine Phosphate 11. Chloroquine Sulfate 12. Chloroquine Hydrochloride
13. Cimetidine 14. Ciprofloxacin Hydrochloride 15. Codeine phosphate 16. Diclofenac Potassium 17. Diclofenac Sodium 18. Doxycycline Hyclate
19. Efavirenz 20. Enalapril Maleate 21. Ethambutol Dihydrochloride 22. Fluconazole 23. Folic acid 24. Furosemide 25. Ibuprofen 26. Isoniazid
27. Ketoprofen 28. Lamivudine 29. Levetiracetam 30. Levofloxacin 31. Mefloquine Hydrochloride 32. Metoclopramide Hydrochloride
33. Metronidazole; and its erratum 34. Nifedipine 35. Piroxicam 36. Prednisolone 37. Prednisone 38. Primaquine Diphosphate
39. Proguanil Hydrochloride (accepted for publication) 40. Propranolol Hydrochloride 41. Pyrazinamide 42. Quinidine Sulfate
43. Quinine Sulfate 44. Ranitidine Hydrochloride 45. Ribavirin 46. Rifampicin 47. Stavudine 48. Verapamil Hydrochloride
FIP-MEPS webinar – Mass vaccination campaigns
Speakers: Petra Straight, Steve Shaddock.
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