Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms

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Announcement of meeting and invitation to participate

Ottawa, Ontario
11 June 2010

This Notice announces a forthcoming meeting of the Health Products and Food Branch (HPFB) Scientific Advisory Panel on Bioequivalence Requirements for Modified-Release Dosage Forms (SAP-MRDF) and associated workshop. The workshop, which is to precede the SAP-MRDF meeting will be open to all stakeholders and participation is hereby invited.

The purpose of this workshop is to obtain recommendations, in consultation with stakeholders, on the adequacy of current HPFB comparative bioavailability standards. Recommendations, made to HPFB by the SAP-MRDF, will contribute to the development of guidance where appropriate. Please note, however, that until such time as the relevant guidance is finalized and published, current comparative bioavailability requirements remain unchanged and recommendations resulting from the meeting will not be implemented.

Mandate of the SAP-MRDF

To provide timely scientific, medical and clinical advice on appropriate comparative bioavailability standards for modified-release dosage forms of pharmaceutical drugs, in particular for those drugs where concerns have been raised that existing standards may not be adequate, for example, methylphenidate and nifedipine.

For more details, please refer to the Terms of Reference of the SAP-MRDF.

Workshop format

The structure of the workshop, scheduled for the morning of 11 June 2010, is intended to allow for direct stakeholder involvement and greater transparency in policy development. All stakeholders are invited to attend this workshop. Only one topic will be dealt with, in order to give the panel adequate time to deliberate and make recommendations to HPFB. The working language of this workshop will be English.

After a brief inaugural presentation by the Therapeutic Products Directorate, selected invited stakeholders will make a series of brief presentations on the issue of comparative bioavailability requirements for modified-release dosage forms in cases where the reference product is claimed to exhibit a unique pharmacokinetic profile (for example, biphasic release). Examples of drugs, in modified-release dosage forms, for which special pharmacokinetic profiles have been claimed to be clinically desirable or necessary are methylphenidate and nifedipine. On completion of all presentations and associated discussion, the panel will deliberate in a closed meeting before making final recommendations to Health Canada.

Agenda

The detailed agenda for the workshop will be posted at a later date.

As new technologies emerge for modified-release dosage forms that result in distinct drug-release patterns, Health Canada wishes to evaluate whether the current metrics and standards for demonstrating bioequivalence of modified-release products are sufficient to assess all modified-release dosage forms.

Therefore in preparing presentations or comments, we ask that you consider questions such as those outlined below.

1. Are current comparative bioavailability metrics and standards¹ adequate for modified-release dosage forms?
2. If current metrics and standards are considered inadequate, what metrics and standards would you recommend and under what circumstances would they be applied? Proposals should be supported by scientific rationales and data.

Procedure

If you wish to attend the workshop, either as a presenter or an observer, please inform the contact person identified below, by 15 May 2010. There is no charge for registration. However, your registration information is necessary for planning, as the number of registrants will determine the venue for the meeting. Registration will be limited to 60 persons, and will be accepted on a first-come, first served basis. However, in order to allow the widest possible representation, the number of registrants per organization may need to be limited.

If you wish to make a presentation, please submit a brief abstract (up to one page) of your proposed presentation along with a copy of your curriculum vitae, including contact information, to the contact person identified below, by 21 May 2010. Unfortunately we can only accommodate a limited number of presentations given the planned length of the workshop. Presenters will be selected by the Therapeutic Products Directorate based on the material submitted. We will endeavour to ensure that all groups of stakeholders are represented. Selected presenters will be asked to submit their presentations to the Directorate.

It is anticipated that not all interested stakeholders will be able to attend the meeting. If you are unable to attend the meeting (or are not selected to make a presentation at the meeting) and wish to comment on the issue in writing, please do so by 28 May 2010. You may submit comments by mail or email to the contact person identified below.

Date and times

Workshop: 11 June 2010 (08:30 to 12:00) (times approximate)
SAP-MRDF deliberations: 11 June 2010 (13:00 to 17:00) (times approximate)
Deadline for registration for the meeting: 15 May 2010
Deadline for submission of abstracts to be considered for presentations: 21 May 2010
Deadline for submission of written comments: 28 May 2010
Deadline for electronic copy of presentations to reach Health Canada: 16:00 (Eastern time)
4 June 2010

Please see the agenda to be posted on Health Canada website for approximate presentation times. Presenters will also be informed by email of their approximate presentation times.

Location

Hampton Inn Ottawa and Conference Centre
200 Coventry Road
Ottawa, Ontario
K1K 4S3
Tel: 1-613-741-2300
Fax: 1-613-667-9888
Complimentary underground parking is available on site

Contact Person

Ms. Marilyn Davis
Therapeutic Products Directorate
Tower B, Holland Cross, Address Locator 3102C3
1600 Scott St. (Room 2071)
Ottawa, Ontario
K1A 1B6
Telephone:(613) 957-6260
Facsimile: (613) 941-5035
e-mail: Marilyn.Davis@hc-sc.gc.ca

Please complete the following form and return by fax or email.

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Scientific Advisory Panel - Modified-Release Dosage Forms

Workshop Registration Form
11 June, 2010, Ottawa^*

Name
Title
Organization
Address
City
Province
Postal Code
Phone
Fax
Email

Registration Requirements (Please Check)
Wish to present
Wish to present but will still attend if not selected
Request observer status only
Comments (Attach sheets if necessary)

* Further details will be posted on the Health Canada website as they become available.

¹ See Therapeutic Products Directorate Guidance for Industry: Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part B: Oral Modified Release Formulations (1996).