[106-FL] Free Phoenix Templates for Bioequivalence Regulatory Guidances

Content
6 modules

Difficulty
Intermediate

Rating

Course Length
8 hours

Instructor
Ana Henry

Price
Free

Description

Complimentary Phoenix Templates for Bioequivalence.

Several easy-to-use Phoenix templates, that require minimum user input, have been developed to address a series of BE regulatory guidances.  In this course, we discuss the purpose of each Phoenix workflow template,  show you how to download templates, and teach you and how to use them.

Course Content:

  • Module 1: Template Downloads
  • Module 2: Assessing Reference Scaled Average Bioequivalence (RSABE) for Highly Variable Drugs (HVD) - FDA + EMA
  • Module 3: Assessing Reference Scaled Average Bioequivalence (RSABE) for Narrow Therapeutic Index Drugs (NTID) - FDA
  • Module 4: Assessing Bioequivalence to Methylphenidate Hydrochloride (Concerta) - FDA
  • Module 5: Assessing ABE and PBE for In Vitro Data of Inhaled Products (Guidance on Budesonide) - FDA

1.
Template Downloads
{{ vm.helper.t('reports.module') }}
2.
RSABE for Highly Variable Drugs (HVD)
{{ vm.helper.t('reports.module') }}
3.
Narrow Therapeutic Index Drugs (NTIDs)
{{ vm.helper.t('reports.module') }}
4.
BE Analysis to Methylphenidate Hydrochloride
{{ vm.helper.t('reports.module') }}
5.
ABE and PBE for In Vitro Data (i.e., Particle Size) of Oral Inhaled and Nasal Drug Products (ONDPs).
{{ vm.helper.t('reports.module') }}
6.
Course Feedback Survey
{{ vm.helper.t('courses.survey') }}
 
Added 1 day ago, by Katherine
 
Added 6 days ago, by Cinzia
 
Added 24 days ago, by Geetha
 
Added about 2 months ago, by Angeliki
Very useful and interesting course. Thank you for providing this for free. I think it would also be useful to have the RSABE templates validated. Thank you.
 
Added about 2 months ago, by dario
 
Added about 2 months ago, by Ahmed
 
Added 3 months ago, by Patel
Informative and usefull courses
 
Added 3 months ago, by MARTHA
 
Added 9 months ago, by Segun
 
Added 10 months ago, by Anonymous

Note: the launching of a new Certara website makes it necessary to publish a new versions of these Terms and Conditions for Certara University.  The Certara "Privacy" link below has a new URL.  The rest of the terms are unchanged from the previous version.

User Accounts and Registrations

The email address used for your user login must be an individual account.  No sharing of user accounts between multiple individuals is allowed.  Each user account (and any associated course registrations) is for a specific person, and cannot be transferred to a different individual once the course has started.  

Course Materials

As a course registrant, you may view and read all materials related to your registered courses. However, you may not share, communicate, publish, copy or in any manner distribute to other parties the course materials, reference material provided, assignment solutions, quiz questions, exam questions, links or any other materials. 

Cancellation Policy

Classroom Courses

Certara retains the right to cancel sessions, if 30 calendar days before the first day of class, there are fewer than five students enrolled.  Participants should wait to book nonrefundable travel until they receive confirmation from Certara that a class has sufficient registrations to proceed.   

If a scheduled class is cancelled, Certara will notify enrolled students at least thirty calendar days before the first day of the scheduled class and the full cost of the course would be refunded. Certara will not be responsible for any airfare, accommodation or other costs incurred by registrants in the event a course is cancelled for any reason. If Certara cancels a course within 30 days for any unforeseen reason a full refund will be issued and airfare exchange fees may be refunded.

If you cannot attend the session for which you have enrolled, you can (1) choose a different session of the same course, (2) have another person attend in your place, or (3) you may be able to get a full or partial refund, based on the number of days prior to the session, as shown in the table.  

Notification of Cancellation by Participant Amount of Refund
1-30 Calendar Days 0% Refund
31-59 Calendar Days 50% Refund
60 Calendar Days or More 100% Refund

Live Online Courses

There are no refunds for Live Online courses.  Certara retains the right to cancel the course 30 calendar days before the first session, in which case participants will receive a full refund.

e-Learning and Certifications

There are no refunds for e-Learning courses or certifications.  Course expiration dates can be found on your Dashboard.

Electronic Communication

We will send you email notifications regarding your training courses, including enrollment confirmations, purchase confirmations, and reminders of upcoming sessions.  We will also send email for general announcements about the site.  You can opt out of these emails if you wish (located in your profile).

Details 

Full terms and conditions applicable to this LMS are available at the Certara Legal web page.

Updated: Certara is committed to protecting your privacy.  Details of our privacy policy are available at the Privacy web page. 

Shopping Cart

Your cart is empty