The GastroPlus PHARMACEUTICAL Development Workshop
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United States of America
27 September 2018
This two-day, hands-on course provides a working knowledge of the theories and application of our state-of-the-art PBPK modeling and simulation software to support internal research and regulatory interactions. A combination of presentations and interactive examples, taken from actual industry experience and using GastroPlus, illustrate how to recognize and deal with the multiple interacting phenomena that affect the absorption, pharmacokinetics, BABE and helpful for generic drug industry.
Hands-on training, Lecture
Optional / Voluntary
This workshop is appropriate for sciensts in pharmaceutical development who need an in-depth understanding of how formulaon affects the highly interactive processes of dissolution, precipitation, gastrointesnal transit, absorption (passive and carrier-mediated),
first-pass metabolism and pharmacokinetics. Although the course will use GastroPlus for
all case studies, the guiding principles will be taught in a software-independent manner.
Class size is limited to encourage interaction with the course instructors and among delegates.
Professionals (e.g. veterinarians), Scientific officers / Project managers, Managers, Technicians, Teachers and educators, Regulators and policy-makers, Researchers, Students
SMEs, Consulting, Contract Research Organizations (CROs), Governmental bodies, Industry, Academia
Postdoctoral (teaching and research), University (Doctoral education), University (Master), Continuing Professional Development
Full coverage (a dedicated course)
|Details on the topic or technology covered:||
Please also check the attached pdf file for training programme as well.
1. Welcome and an overview of the GastroPlus™ PBPK modeling platform
2. Applicatons: QSAR/PBPK modeling integration– defining inputs through chemical structures and in silico F% simulations in animals and humans
3. Application: Mechanistic dissolutions modeling (aqueous solubility vs. pH,
biorelevant solubility, preformulaon assessment, parcle
4. Applications: Mechanistic dissolution & precipitation modeling (Z-factor options, precipitation kinetic features)
5. Applications: Mechanistic oral absorption modeling (the ACAT™ model, ASFs, paracellular absorption)
1.Applications: Systemic PK modeling considerations (PKPlus™ Module)
2. Applications: Mechanistic IVIVCs and virtual bioequivalence trials
3. Applications: Mechanistic IVIVCs and virtual bioequivalence trials (integration with DDDPlus™ for dissolution speciﬁcations)
4. Applications: Formulation optimization to hit target PK proﬁles
5. Applications: Additional dosage routes: Mechanistic dermal absorption models and IM models
6. Applications: Incorporating mechanistic modeling and simulation to assist with formulation development and regulatory evaluations
What will you learn?
Upon completion of this course you will have a thorough understanding of the interactions that exist among the various mechanistic phenomena aﬀecting drug dissolution, absorption and pharmacokinetics and how they relate to the development of drug products both in preclinical and clinical settings.
You will gain experience in:
Assessing formulation strategies (e.g., micronization and nanoparticles) earlier in product development
Analyzing the impact of common ion eﬀect on solubility & dissolution
Screening for diﬀerent salts and understanding the eﬀect on precipitation kinetics
Properly using in vitro dissolution data to predict plasma concentration levels
Deconvoluting in vivo dissolution to help design in vitro experiments and generate mechanistic IVIVCs
Estimating local concentration of drug following dermal and intramuscular administration
Running virtual bioequivalence studies to estimate sample sizes and achieve adequate power
Understanding optimization methods, objective function weighing and constraints
Designing controlled release products to reach therapeutic “windows” or target concentration proﬁles
|Accreditation body and/or authority that approved the education or training:||
Electrolab Certified Course
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