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. Under the leadership of Dr Dirk Barends of the Dutch National Institute for Public Health and the Environment, the FIP Special Interest Group (SIG) on Biopharmaceutics Classification System (BCS) and Biowaiver started to collect publicly available information for Essential Medical Drug Products based on the biopharmaceutical classification system. This activity now continues under the leadership of Prof. Jennifer Dressman, Goethe University, Frankfurt am Main, Germany. This project is supported by the World Health Organization (WHO) and takes published guidance of the WHO, the US Food and Drug Administration and the European Medicines Agency into consideration as well as scientific developments in this field. The collected information is critically reviewed and published as monographs in the Journal of Pharmaceutical Sciences, the official journal of FIP's Board of Pharmaceutical Sciences. Almost 50 monographs have been published so far. Click here for the progress table, showing the monographs in preparation and their first authors. The selection of drug candidates for future biowaiver monographs is primarily based on the WHO Essential Drug List, in order to assist approval of generic drug products in a facile and objective manner, with the aim of improving access to reliable medicines, especially developing countries. Other drugs that are widely used can also be considered for biowaiver monographs. 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 40. Propranolol Hydrochloride 41. Pyrazinamide 42. Quinidine Sulfate 43. Quinine Sulfate 44. Ranitidine Hydrochloride 45. Ribavirin 46. Rifampicin 47. Stavudine 48. Verapamil Hydrochloride 49. Zidovudine (Azidothymidine (Fip.Org.) |