Date to be announced
Contact us for more infoTRAINING TIMES
The statistical design needed to get regulatory approval. Connecting the dissolution data to pharmacokinetics.
Avoid errors in connecting the dissolution data to PK. Understand the value of statistics in biostudies.
Predictive Power of Dissolution and Alternatives to Full BE. Master the project management of bioequivalence studies.
What to look for when auditing a biostudy in terms of validation? Connect science with regulatory expectations.
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
Fundamentals of pharmacokinetics, Pharmacokinetic variables, The regulatory demands for study design in bioequivalence guidelines, Narrow therapeutic index drugs
Estimation of statistical power and size of study as related to the drug absorption variability. Sample size determination, Fasting/fed studies, Modified release.
Statistics with HVD(P)s and NTIDs: equivalence acceptance criterion based on variability of the reference. Estimation of variability and its uncertainty.
Dissolution & IVIVC Guidelines. Challenges for in vitro representativeness. Absorption rate determination. Time scaling. Prediction of plasma concentrations. Development of IVIVC, applications of IVIVC.
Pilot pK Studies, alternatives to Full BE, BCS biowaivers, biowaivers of additional strengths.
The requirements of GMP and GCP as applied to bioequivalence
Designed for professionals who want to enhance their expertise and advance their careers
Dynakin, Senior Associate
Paula Muniz is a Senior Associate with Dynakin’s Drug Modeling & Consulting (DMC) group. She is a Doctor in Pharmacy at the University of Navarra with a PhD. in cardiovascular pharmacology. She is also a MSc in Clinical Research from the University of Cardiff and an MBA from the Barcelona School of Management from Pompeu Fabra University. Paula has more than 15 years of experience within the pharmaceutical industry in an international setting where she has worked on regulatory strategy, clinical study design and result evaluation in several indications for a NCE and a fixed dose combination for EMA and FDA submissions. Focusing on comparative bioavailability, in vivo in vitro relationships/correlations, and pragmatic application of regulatory requirements, she has participated in the development of numerous complex immediate and modified release pharmaceutical alternatives for oral, inhalation, and intramuscular routes. She has also set up and participated in scientific meetings with EMA, national authorities, and the FDA. Since her initial involvement with Dynakin she has built experience in the regulatory application of modeling & simulation and population PK/PD methods for the evaluation of interactions, pediatric product development, and bridging between populations. We are live on webchat!
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