Shruti Bhat PhD, MBA, Lean Six Sigma Black Belt
  • Home
  • Consulting
  • Workshops
  • Articles
  • Patents
  • Publications
  • Books
  • Videos
  • Blog
  • Contact

USFDA Unveils Two Draft Guidance Documents to Facilitate Generic Development of Transdermal and Topical Dosage Forms

10/9/2018

0 Comments

 
The United States Food and Drug Administration (USFDA) today 9th October 2018, unveiled one revised draft guidance and another new draft guidance to help advance the development of generic Transdermal/Topical Delivery Systems (TDS). Here's a snapshot:

When applied to a patient’s skin, Transdermal/ Topical products are expected to deliver the correct dose of the medication consistently and for the expected length of time, while adhering consistently and uniformly to the skin, even when the skin is exposed to water, humid environment and/or body movement.
revised fda guidelines for transdermal patch and topical products
revised usfda guidelines for transdermal and topical products
Because of the inherent complexity of delivering a drug through a transdermal/ topical system, making generic copies of these branded (reference listed) transdermal/ topical drug products is hard; and the two draft guidance documents aim to mitigate this problem.

ANDA Guidance document for assessing Irritation and Sensitization:

This 12-page guidance provides recommendations for Abbreviated New Drug Application (ANDA) sponsors on the design and conduct of studies to evaluate the in vivo skin irritation and sensitization (I/S) potential of a proposed transdermal or topical delivery system.

Applicants must perform a comparative assessment of the generic and reference listed transdermal/topical drug products using an appropriately designed skin I/S study with human subjects. The draft document demonstrates that the potential for a skin irritation or sensitization reaction with the Test-TDS is no worse than the reaction observed with the Reference-TDS.

Study design and conduct, considerations for statistical analysis, overall assessment of adverse event data and format of data submissions are outlined in the draft guidance. (Note: The recommendations relating to the design and conduct of I/S studies described in this guidance replace the recommendations related to I/S studies provided in product-specific guidances published before this guidance. This set the stage for revisions in bioequivalence (BE) study guidelines for 23 TDS products).

ANDA Guidance document for Assessing Adhesion

This revised 9-page draft guidance supersedes a draft from June 2016 and provides recommendations for the design and conduct of studies evaluating the adhesive performance of a TDS.

Apropos the guidance document, depending on the objective(s) of a transdermal/ topical dosage form product development program, applicants may choose to evaluate transdermal /topical adhesion in clinical studies performed to evaluate adhesion only or in clinical studies performed with a combined purpose (example- for simultaneous evaluation of adhesion and bioequivalence (BE) with pharmacokinetic (PK) endpoints).

Additional topics covered in the revised draft include the study design and conduct, considerations for statistical analysis, as well as recommendations on the combined evaluation of adhesion and bioequivalence.
Follow Shruti on Twitter, Facebook, YouTube, LinkedIn 

#TransdermalPatch #USFDAGuidanceForTransdermalDrugDelivery
References:
  1. Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry
  2. Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry
0 Comments

Your comment will be posted after it is approved.


Leave a Reply.

    New Book Released!

    kaizen for pharmaceutcials, medical devices and biotech industry book by Dr Shruti Bhat

    Shruti's YouTube Channel ...

    Picture
    Picture

    Shruti Bhat
    PhD, MBA
    Certified Lean Six Sigma Black Belt

    ​Shruti is a ​Global Leader in Lean Innovation, Lean Manufacturing, Business Transformation and Continuous Improvement; Best-Selling Author and Speaker.

    Shruti is a Go-To Scientific Expert and Management Leader within Pharmaceutical, Health Care, Device Technology, Bio- Technology, Life Sciences, Retail industry  and affiliated verticals.

    Shruti is a true 
    Thought Leader, who has ​accomplishments, awards, books, patents and several publications in peer reviewed journals. ​
    Read more

    Shruti's books...

    Picture
    shruti bhat, business process management, continuous improvement
    Picture
    Book on Continuous improvement tools by Dr Shruti Bhat
    kaizen for leaders, continuous process improvement tool to increase profit and organizational excellence by shruti bhat
    kaizen, shruti bhat, continuous improvement, quality, operations management

    Blog Categories

    All
    3D Printing
    5S
    Agile
    Automation
    Balanced Score Card
    Biotechnology
    Books
    Business Turnaround
    Case Studies
    Change Management
    Chemical Industry
    CMMI
    Continuous Improvement
    Design Thinking
    Digitalization
    Drug Delivery
    External News Links
    Food Industry
    Hall Of Fame
    Health Care
    Hoshin Kanri
    HR Development
    Innovation
    ISO
    Just In Time
    Kaizen
    Leadership
    LEAN
    Lean Six Sigma
    Life Sciences
    Manufacturing
    Medical Devices
    Mistake Proofing
    Motivational Cards
    Nanotechnology
    Operations
    Packaging
    Patents
    Personal Products
    Process Improvement
    Product Development
    Productivity Increase
    QbD
    Quality Management
    Robotics
    Service Industry
    Six Sigma
    Strategy
    Supply Chain Logistics
    Telecom Industry
    TQM
    Videos
    Voice Of Customer
    Workshops

    Micro-Learning
    ​Partner

    Picture

    Publishing Partner

    fast read books, business management books, health and wellness books, spiritual guidance books, best online book store

    Wellness
    ​Partner

    Picture
© Copyright 1992- 2022 Dr. Shruti Bhat ALL RIGHTS RESERVED.
See Terms and Conditions on this site usage.
SHRUTI BHAT, CONTACT
Click to connect.
Created by Macro2Micro Media