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Biowaiver monographs. What are biowaiver monographs?
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

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Biowaiver monographs. What are biowaiver monographs?