Biowaiver monographs

submenus:

Under the leadership of Dr Dirk Barends of the Dutch National Institute for Public Health and the Environment (RIVM) the FIP-BPS Special Interest Group (SIG) Biopharmaceutics Classification System (BCS) and Biowaiver started to collect publicly available information for Essential Medical Drug Products based on the Biopharmaceutical Classification System (BCS). This activity now continues under the leadership of the current Chair of the Focus Group "BCS and Biowaiver", Prof. Jennifer Dressman of the Goethe University in Frankfurt am Main, Germany. This project is supported by WHO and takes published guidances of the WHO, FDA and EMA into consideration as well as scientific developments in this field. The collected information is critically reviewed and published as monographs in Journal of Pharmaceutical Sciences. They are also made available on the FIP Website below. Up till now, more than 30 monographs have been published and more will follow. The selection of drug candidates for future biowaiver monographs is primarily based on the "Essential Drug List"of WHO, 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.

Although the monographs have no formal regulatory status, they represent the best scientific opinion currently available. They are published in the Journal of Pharmaceutical Science but can also be downloaded free of charge by clicking on the link in the list below. It is foreseen to update the monographs with addenda if new data becomes available.

  

  1. Acetaminophen = Paracetamol (click here)
  2. Acetazolamide (click here)
  3. Acetylsalicylic acid (click here)
  4. Aciclovir (click here)
  5. Amitriptyline Hydrochloride (click here)
  6. Amodiaquine Hydrochloride (click here)
  7. Amoxicillin trihydrate (click here)
  8. Atenolol (click here)
  9. Bisoprolol fumarate (click here)
  10. Chloroquine Phosphate (click here)
  11. Chloroquine Sulfate (click here)
  12. Chloroquine Hydrochloride (click here)
  13. Cimetidine (click here)
  14. Ciprofloxacin Hydrochloride (click here)
  15. Codeine phosphate (click here)
  16. Diclofenac Potassium (click here)
  17. Diclofenac Sodium (click here)
  18. Doxycycline Hyclate (click here)
  19. Efavirenz (click here)
  20. Enalapril Maleate (click here)
  21. Ethambutol Dihydrochloride (click here)
  22. Fluconazole (click here)
  23. Folic acid (click here)
  24. Furosemide (click here)
  25. Ibuprofen (click here)
  26. Isoniazid (click here)
  27. Ketoprofen (click here)
  28. Lamivudine (click here)
  29. Levetiracetam (click here)
  30. Levofloxacin (click here)
  31. Mefloquine Hydrochloride (click here)
  32. Metoclopramide Hydrochloride (click here)
  33. Metronidazole (click here); and its erratum (click here)
  34. Nifedipine (click here)
  35. Piroxicam (click here)
  36. Prednisolone (click here)
  37. Prednisone (click here)
  38. Primaquine Diphosphate (click here)
  39. Proguanil Hydrochloride (submitted for publication)
  40. Propranolol Hydrochloride (click here)
  41. Pyrazinamide (click here)
  42. Quinidine Sulfate (click here)
  43. Quinine Sulfate (click here)
  44. Ranitidine Hydrochloride (click here)
  45. Ribavirin (click here)
  46. Rifampicin (click here)
  47. Stavudine (click here)
  48. Verapamil Hydrochloride (click here)
  49. Zidovudine (Azidothymidine) (click here)

Click here for the progress table, showing the monographs in preparation and their first authors.

 

Additions and updates of published Biowaiver Monographs

  • Metronidazole (Journal of Pharmaceutical Sciences, Vol.100, No.5, May 2011):
    The link under reference #15 should read: http://www4.anvisa.gov.br/BularioEletronico/, then search for "metronidazol" in the line "nome do principio ativo".
    On the next page, go for the third option "metronidazol Flagyl (Sanofi-Aventis Farmacêutica Ltda) comprimido revestido 250 mg e 400 mg".
  • Erratum Metronidazole monograph (click here)

 

Number of downloads of published monographs

Number of monographs downloaded from the Journal of Pharmaceutical Sciences (JPS), click here

 

Are you interested in writing a biowaiver monograph too? Contact the corresponding author of the series at Dressman@em.uni-frankfurt.de. For guidance to writing such a monograph, click here.

Do you have data not yet covered in one of these Biowaiver Monographs? Or comments? Or general comments on biowaivers or biowaiving? The Discussion Forum on Biowaiver Monographs which is open to everybody, invites you to post your additional data and comments to specific monographs, or make general comments!