Regulations on biowaivers already existed at that time, according to which an in vitro instead of an in vivo assessment could be used to assess bioequivalence for a new tablet or capsule, or a new formulation of an existing immediate release dosage form. On the basis of the in vitro assessment, a new drug product could be considered bioequivalent to its reference product, without having to perform a pharmacokinetic study in human volunteers. To generally describe the use of an in vitro assessment to waive the need for in vivo (bio) studies, the term biowaiver was coined. As this term was originally applied to waiving in vivo studies for registration of lower dosage strengths of drug products, the more precise term "BCS based biowaiver" is sometimes used to distinguish biowaivers based on BCS considerations from biowaivers used for the approval of lower dose strengths of a product.
Dipl. -Ing. Hans Anthony, ST
He was born in Dabo Singkep, Riau in 1987. He completed his study by receiving his Dipl.-Ing and Bachelor of Engineering Degree in Pharmaceutical Engineering Department from Swiss German University. He was graduated with Cum-laude and his thesis is patent registered with the title 'Production of Pharmaceutical Hard Capsule Shell from Corn Starch'. He was appointed as the Managing Director of PT. Pharma Test Indonesia after finishing a complete training in Pharma Test Headquarter, Germany.
He was born in Sukabumi in 1988. He finished his study in Physical Instrumentation Department of University of Indonesia. Prior to joining PT. Pharma Test Indonesia, he has work experiences in several companies such as PT. Telkom Indonesia and PT. Airfast Indonesia. He has good personality and a hard worker. He joined PT. Pharma Test Indonesia in 2010 and has been attended the training in Pharma Test Headquarter in Germany.