Additional Dosage Routes Seminar Series

 

June 1 - 5, 2020

8 AM PST (Los Angeles)
11 AM EST (New York)
5 PM CET (Paris)

Schedule:

 

+ Monday 6/1 Pulmonary (PCAT) & Oral Cavity (OCCAT)

 

 

+ Tuesday 6/2 Transdermal (TCAT) 

RE-SCHEDULED for 6/10

 

 

+ Wednesday 6/3 Intramuscular & Subcutaneous 

 

 

+ Thursday 6/4 Ocular (OCAT)

 

 

+ Friday 6/5 "Ask Us Anything"

 

Panel discussion with Michael Bolger, Viera Lukacova, John DiBella, Sandra Suarez-Sharp, Grace Fraczkiewicz, Jim Mullin, Ke Szeto, Jessica Spires, and Maxime Le Merdy.

Monday, June 1st – Pulmonary & Oral Cavity
 
The Pulmonary Compartmental Absorption & Transit (PCAT™) model represents the lung/nose as a collection of the following compartments: an optional nose (containing the anterior nasal passages), extra-thoracic (naso- and oro-pharynx and the larynx), thoracic (trachea and bronchi), bronchiolar (bronchioles and terminal bronchioles) and alveolar-interstitial (respiratory bronchioles, alveolar ducts and sacs and interstitial connective tissue).
 
The Oral Cavity Compartmental Absorption & Transit (OCCAT™) model represents the oral cavity (mouth) as a collection of the following compartments: buccal, gingival, palate, top of the tongue, bottom of the tongue, and mouth floor.
 
View Journal Article: IVIVC using in silico and PBPK methods for inhaled drug product development
 
View Journal Article: Changes in murine respiratory dynamics induced by aerosolized carfentanil inhalation: Efficacy of naloxone and naltrexone
Tuesday, June 2nd – Transdermal [RE-SCHEDULED for Wednesday, June 10th]
 
The Transdermal Compartmental Absorption & Transit (TCAT™) model represents the skin as a collection of the following compartments: stratum corneum, viable epidermis, dermis, subcutaneous tissue, sebum, hair lipid, and hair core.
 
View Video: Understanding dermal drug dispostion using TCAT - a novel PBPK model
 
View Journal Article: A next generation risk assessment case study for coumarin in cosmetic products

Wednesday, June 3rd – Intramuscular
 
The intramuscular (IM) drug delivery model represents the site of injection as a single compartment. Within this compartment, drug can be bound, and local clearance can take place. Drug can also be transported into the lymph or systemic circulation. 
 
GastroPlus now provides two intramuscular (IM) dosage forms, both of which assume that drug is injected into the muscle tissue. One of these is an immediate release (IR) dosage form, with the other treated as controlled release (CR).
 
View Poster: Physiologically based pharmacokinetic (PBPK) model for intramuscular injection of aripiprazole
 
View Journal Article: Changes in murine respiratory dynamics induced by aerosolized carfentanil inhalation: Efficacy of naloxone and naltrexone
Thursday, June 4th – Ocular
 
The Ocular Compartmental Absorption & Transit (OCAT™) model represents the eye as a collection of the following compartments: pre-cornea, cornea, conjunctiva, aqueous humor, anterior sclera, posterior sclera, iris-ciliary body, choroid-RPE (a combination of choroid and the retinal pigment epithelium), retina, anterior and posterior vitreous humor.
 
View Journal Article: Physiologically Based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development 
 
View Journal Article: Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension
 
View Presentation: Developing PBPK for Ocular Delivery
Friday, June 5th – Ask Us Anything panel discussion (all instructors)
 
 
All of the ADR models were developed in collaboration with top pharmaceutical companies and/or the U.S. FDA.
 
Prerequisite:
+ Familiarity with setting up and running basic GastroPlus simulations,
+ including database & support file structures,
+ basic inputs for physicochemical & pharmacokinetic parameters,
+ and basic physiology options for human & animal simulations