Webinar on

Bioavailability and Bioequivalence

March 30, 2021

Scientific Program

Keynote Session:

Meetings International -  Conference Keynote Speaker KATERYNA ZUPANETS photo

KATERYNA ZUPANETS

National University of Pharmacy, Ukraine

Title:  BIOPHARMACEUTICAL DIFFERENCES OF HERBAL DRUGS AND THEIR PHYTOSIMILARS

Biography:

Kateryna Zupanets as a clinical pharmacist completed her PhD at the age of 27 years from National University of Pharmacy (Kharkiv, Ukraine) and last year she finished her post-doctoral studies at Clinical and Diagnostics Centre of the National University of Pharmacy. She is the author of more than 50 papers in reputed journals (6 articles for SCOPUS journals). Dr. Zupanets has been working as a Co-Investigator in more than 50 trials of Bioequivalence studies and Phase I (Clinical and Diagnostics Center of the National University of Pharmacy).

Abstract:

In the epoch of antibiotic resistance and drug-dependent side effects the herbal drugs become more and more popular. According to the evidence level (EPOS 2012) herbal drugs hold Ib rate with the corresponding Grade A recommendation. The present parameters are the same as for Paracetamol. This fact is extremely reliable cause in terms of their potential herbal drugs can definitely be used to treat colds. As far as herbal medicines are as old as human kind they are well-studied and form the basis of modern pharmaceutics. Despite a huge variety of plant-based medicines and healing activities of natural substances they are still yielding surprising insights. For example, anti-inflammatory activity is not determined by one or other compound alone, it’s a result of correct composition. But it doesn’t mean that all herbal drugs with the similar content possess the same pharmacological activity. According to our in-depth studies of herbal medicine pharmacological activities we came up with an idea that there are no generics among herbal drugs. When studying a number of plant-based medicines such as novel dry extract BNO 1011 (Sinupret® extract), BNO 1045 (Canephron® N), micronized purified flavonoid fraction (Detralex®), significant biopharmaceutical differences were found in comparison with their copies, more precisely with phytosimilars. Although different manufactures can copy the ingredients and doses of raw material of well-known brands but it doesn’t maintain the same safety and efficacy. We have found out that phytoneering herbal drugs prove to be as effective as standard therapy due to the unique high-tech approach. Thus, standardized herbal drugs with scientifically determined efficacy are setting new reliable benchmarks which may help to treat diseases in a targeted and effective fashion.

Meetings International -  Conference Keynote Speaker YUAN CHEN photo

YUAN CHEN

Genentech, USA

Title: E-BABE- UNDERSTANDING OF PIRFENIDONE PHARMACOKINETICS IN BIOEQUIVALENCE STUDY USING PBPK APPROACH

Biography:

Yuan Chen is a Principal Scientist in the Department of Drug Metabolism and Pharmacokinetics at Genentech. Yuan has nearly 20 years of experience in the drug metabolism and pharmacokinetics discipline working at Roche and Genentech. She has been DMPK project lead for many drug discovery and development projects, and contributed to many clinical candidate nomination and filing of IND to the regulatory authorities. Yuan’s current research focus is on physiologically-based pharmacokinetic (PBPK) modeling for the prediction of human PK, absorption, and CYP-and transporter-mediated drug-drug interactions. She leads PBPK effort at Genentech and has been active member on IQ PBPK expert working groups.

Abstract:

Pirfenidone is the first treatment approved to treat Idiopathic Pulmonary Fibrosis (IPF). Film-coated tablets were developed to offer an alternative to the marketed capsule formulation, and the bioequivalence (BE) study of pirfenidone after single-dose of tablet and capsules under fasted and fed states were assessed.  A physiologically-based pharmacokinetic (PBPK) model was developed to describe pharmacokinetic (PK) for pirfenidone under fasted and fed conditions. The mechanistic absorption model simulation captured the observed BE study data and explained the phenomenon of Cmax slightly exceeding the BE criteria based on the hypothesis of slower disintegration with capsule under fed condition. The PBPK simulation result further supports the conclusion that the small difference in Cmax between the tablet and the capsules observed in the fed state is not expected to have clinically meaningful impact on the benefit-risk profile of pirfenidone.