Biowaiver monographs

The FIP-BPS Special Interest Group (SIG) Biopharmaceutics Classification System (BCS) and Biowaiver under the leadership of Dr Dirk Barends of the Dutch National Institute for Public Health and the Environment (RIVM) has started to collect publicly available information for Essential Medical Drug Products based on the Biopharmaceutical Classification System (BCS). This activity is supported by WHO and refers to the FDA Guidance of possible biowaivers for class 1 drugs of the BCS. 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. By now, more than 25 monographs are published and more data on class 1 (and class 3) drugs will follow. The selection of possible drug candidates is based on the "Essential Drug List" of WHO in order to assist especially developing countries in getting easy approval by means of a "biowaiver" of generic drug products which belong to class 1 of BCS which are taken up in the database.

These monographs are essentially literature reviews, gathering and organising relevant data to be taken into consideration whether a biowaiver can be recommended for a new formulation of that API. Discussed are: solubility, pharmacokinetics and permeability, dissolution of dosage forms, the therapeutic use and therapeutic window of the API, data on excipient interactions and problems with bioavailability and/or bioequivalence.

The monographs have no formal regulatory status, but represent the best scientific opinions 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.

  • Acetaminophen = Paracetamol (click here)
  • Acetazolamide (click here)
  • Acetylsalicylic acid (accepted for publication)
  • Aciclovir (click here)
  • Amitriptyline Hydrochloride (click here)
  • Atenolol (click here)
  • Chloroquine Phosphate (click here)
  • Chloroquine Sulfate (click here)
  • Chloroquine Hydrochloride (click here)
  • Cimetidine (click here)
  • Ciprofloxacin Hydrochloride (click here)
  • Diclofenac Potassium (click here)
  • Diclofenac Sodium (click here)
  • Doxycycline Hyclate (click here)
  • Ethambutol Dihydrochloride (click here)
  • Furosemide (click here)
  • Ibuprofen (click here)
  • Isoniazid (click here)
  • Ketoprofen (accepted for publication)
  • Lamivudine (click here)
  • Levofloxacin (click here)
  • Mefloquine Hydrochloride (click here)
  • Metoclopramide Hydrochloride (click here)
  • Metronidazole (click here)
  • Prednisolone (click here)
  • Prednisone (click here)
  • Primaquine Diphosphate (click here)
  • Propranolol Hydrochloride (click here)
  • Pyrazinamide (click here)
  • Quinidine Sulfate (click here)
  • Quinine Sulfate (click here)
  • Ranitidine Hydrochloride (click here)
  • Rifampicin (click here)
  • Stavudine (click here)
  • Verapamil Hydrochloride (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)

 

 

Are you interested in writing a biowaiver monograph too? Contact the corresponding author of the series at dirk.barends@rivm.nl. 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!