IV Pan-American Conference BE PANDRH Working Group. Draft - Progress Report. Salomon Stavchansky PhD Alcon Centennial Professor of Pharmaceutics The University of Texas at Austin College of Pharmacy Austin, Texas 78712 firstname.lastname@example.org.
Draft - Progress Report
Salomon Stavchansky PhD
Alcon Centennial Professor of Pharmaceutics
The University of Texas at Austin
College of Pharmacy
Austin, Texas 78712
PAHO -WHO. Dominican Republic March 2, 2005
The II Pan American Conference (November 1999) established the Pan American Network for Drug Regulatory Harmonization (PANDRH)
and rules and regulations for the Network and its working groups.
According to those regulations, harmonized proposals developed by the Working Groups are to be presented at the Conferences for their
adoption or approval.
DISCOVERY DEVELOPMENT DELIVERY
(Q of the product to its expiry date)
RISK TO BENEFIT
Therapeutic Equivalence can be assured when
the multisource product is:
pharmaceutically equivalent and
TE = PE + BE
The concept of interchangeability applies to:
1. - the dosage form and
2. - the indications and instruction for use.
SIMILAR IN VIVO DISSOLUTION
Dissolution of drug in vivo
Drug Concentration in
the Membrane Domain
SIMILAR IN VIVO ABSOPRTION
WHO US DRUGS
325 Medicines 200 Drugs Products
260 Drugs 141 Oral
123 Oral IR 43 On WHO List
Kasim, N. A., et.al. Molecular Pharmaceutics, 1, 85, (2004)
High Solubility Drugs
Source: Amidon, G.L Personal Communication
Is it advisable to grant bio-waivers based on BCS and in vitro Dissolution? If it is advisable, when to grant the bio-waiver?
Waiver of in vivo studies…
Not waiver of bioequivalence
• When both test product and Comparator product are rapidly dissolving, have similar dissolution profiles, and contain a drug substance with high solubility and high permeability (BCS Class I) or
• When the Dosage and Administration section of the Comparator product states that the product should be taken only on an empty stomach, or
• When the Comparator Product label does not make any statements about the effect of food on absorption or administration.
For Modified Release Products, Controlled Release Products
Bioequivalence must be demonstrated under both fasted and fed conditions.When to, and not to conduct Food Effect