Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1 Panel on Topical Dermatologic Products AGDD 2024 | D1S06 - Current Trends in Product-Specific Guidance (PSG) Development & Revisions for
Markham C. Luke from CDER's Office of Generic Drugs discusses product-specific guidances for complex generic drugs. Dow Development Laboratories (DDL): Innovating Topical Drug FDA experts demonstrate the FDA's Generic Drug User Fee Amendments (GDUFA) Science and Research Program's
Recording of the live webinar broadcast on 29th April 2021: Moderator: Michael Scholl, Chief Executive Officer, Leukocare AG 2022 Topical Product Formulation Workshop Session 2 Presentations & Panel Discussion Patricia Onyimba from CDER's Division of Liquid-based Products discusses formulation development considerations,
Katherine Tyner, Associate Director (acting) for Science in CDER's Office of Pharmaceutical Quality, and Christine Le, CDER This includes a discussion on the implementation of quality by design concepts during development to ensure the generic drug product has similar desired quality
In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT Complex Product Characterization/Analysis - Session 2B FDA discusses additional topics in complex generic topical products. Includes responses to audience in a question-and-answer
Darby Kozak from CDER's Office of Generic Drugs discusses in vitro BE for generic topical ophthalmic products: when, how and The emulsions used for the topical delivery of pharmaceutical actives are categorized as macro, nano, and microemulsions. Topical Product Development | Dow Development | Symbio
Panelists: Tannaz Ramezanli, Manfred Bodenlenz, Robert Lionberger, Hiren Patel, Sam Raney, Elena Rantou, Nilufer Tampal, AGDD 2024 | D1S07 - Enhanced Understanding of Structure Performance Relationship Using Modeling
GDF 2024 | D2S08 - Quality Considerations for Topical Ophthalmic Drug Products –Guidance for The Role of Microstructure in Topical Drug Product Development
Topical drug delivery involves drug transport from a product on the skin to a local target site and then clearance by diffusion, metabolism, and the dermal Transdermal and Topical Delivery Systems - Product Development
Advanced in vitro methods in generic drug product development | Recorded Zentiva Webinar Nov 10 2022 FDA discusses additional topics in complex generics, complex injectables, ophthalmic, and otic products. Includes responses to
Priyanka Ghosh, CDER Office of Generic Drugs, discusses product development considerations and approaches to establishing Welcome to Dr. Nick Campitelli's YouTube channel, where groundbreaking medical treatments meet exceptional patient care! In vitro bioequivalence testing for topical ophthalmic suspension products (17of39) Complex Generics
Complex Generics: Topical Products, Part 2 Sam Raney, Tannaz Ramezanli, and Priyanka Ghosh discuss audience questions. Learn more at
Priyanka Ghosh, PhD, Acting Team Lead from the Division of Therapeutic Performance (DTP-I) delivers the introduction to the Topical drug delivery: History, percutaneous absorption, and product How to treat toenail FUNGUS! #shorts
Speakers: Sam Raney, Benjamin Kuzma, Frank Sinner, Tannaz Ramezanli Panelists: Sam Raney, Benjamin Kuzma, Frank Topical Estrogen is a YES. Here is why. #antiaging #skincare Common Deficiencies with ANDAs for Topical Products: (23of39) Complex Generics 2018
AMR R&D efforts in the CMC and formulation arena: Do it right the first time Houston Solution Center: Making the Medical Grade Innovations in Topical Treatments Complex Product Development (3of28) Generic Drugs Forum – Apr. 3-4, 2019
The workshop will review current approaches to the collection of human data during clinical development of topical drug products. The Topical Dosage Forms: Addressing Challenges with cremes Speakers: Priyanka Ghosh, Sameer Sachdeva, Vaibhav Dubey, Romit Jani, Narasimha Murthy, Yousuf Mohammed Panelists:
Introduction to topical drug delivery UPDATE! Here's the deep dive!:
Tannaz Ramezanli from the Division of Therapeutic Performance in the Office of Generic Drugs covers considerations related to Best Practices for Topical Generic Product Development & ANDA Submission–Session 3, Closing Remarks
A presentation and panel discuss new analytical methods that are promising for generic drug development, screening, and Hiren Patel from the Office of Generic Drugs discusses In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and
Finding the right combination of ingredients that deliver the optimal efficacy, sensory attributes, and stability in a topical The use of Pion equipment within Zentiva development is presented. Zentiva is a generic company and thus applications for the Topical drug delivery: History, percutaneous absorption, and product development. Adv Drug Deliv Rev. 2021 Oct:177:113929. doi: 10.1016/j
PBPK to Guide Study Design and Product Development for Generic Dermatological Products Strategies for Generic Topical Product Development (7of35) Complex Generics– Sep. 25-26, 2019
[Nuvisan Talk] How topical product development can be accelerated SUBSCRIBE to @FDALearningCache to see more videos. Details and supporting materials:
2022 Topical Product Formulation Workshop Session 3 Presentations, Panel Discussion, Summary, Close Complex Generics: Topical Products, Part 1
Demonstrating bioequivalence of topical products is a challenging task complicated by variations in drug formulations and testing Sam Raney from the Office of Generic Drugs discusses recent results from GDUFA-funded research into the influence of
CDER Office of Pharmaceutical Quality's Robert T. Berendt covers key considerations during generic drug product development Tannaz Ramezanli, PhD, Pharmacologist from the Division of Therapeutic Performance (DTP-I) presents the Practical
2022 Topical Product Formulation Workshop Session 1 Presentations & Panel Discussion Generic Drug Product Quality Assessment (22of27) Generic Drugs Forum 2018 Kelley Burridge, CDER Office of Pharmaceutical Quality (OPQ), discusses OPQ considerations and how to resolve ANDA
Dermatological Product Development For Managers Generic Topical and Transdermal Products (5of35) Complex Generics– Sep. 25-26, 2019 SUBSCRIBE to @FDALearningCache to see more videos. Details and supporting materials:
Breaking Down The Topical Drug Product Development Process: A FDA discusses topics in complex generic topical products. Includes responses to audience in a question-and-answer panel. FDA AGDD 2024: Session 2: Research to Support Guidance Development for Topical Drug Products
Bioequivalence for Generic Topical and Transdermal (6of35) Complex Generics– Sep. 25-26, 2019 2022 Topical Product Formulation Workshop Welcome & Opening Remarks
This video provides an overview of an impact story on how FDA is creating new ways to evaluate bioequivalence for topical drugs. Best Practices for Topical Generic Product Development and ANDA Submission – Session 2 FDA-registered, cGMP compliant formulation and manufacturing lab, Dow Development, designs, develops and manufacturers topical drug products.
Drug Development Company Commercialising Topical Products for Global Markets Priyanka Ghosh from the Division of Therapeutic Performance in the Office of Generic Drugs discusses transdermal and topical Ever get cold sores? Listen in for my recommendation to help.
Watch the full video at: Most topical formulations developed today are complex and require tight Eleftheria Tsakalozou from the Office of Generic Drugs illustrates how modeling and simulation approaches such as
The aim of this course is to provide a working knowledge of topical product development for managers and senior managers Paper:-Product development Part 2 Subject:-Pharmaceutical Science. A New Possible Way to Evaluate Bioequivalence of Topical Drugs
Amy Ethier, Skin Delivery Formulation Scientist at BASF Pharma, sits down with Pharmaceutical Technology at CPhI North This presentation provided an overview of the draft guidance on quality considerations for topical ophthalmic drug products. Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches
In Vitro Bioequivalence Testing of Topical Generic Products Human Dermal (Skin) Safety Testing for Topical Drug Products Ensure client and product success. Ease technology transfer and scale up. Hold an impeccable quality record. Leaders in the topical pharmaceutical industry with
TOPICAL DRUG DEVELOPMENT -- EVOLUTION OF SCIENCE Jim Polli, Markham Luke, Sam Raney. Tannaz Ramezanli, CDER Office of Generic Drugs, discusses product development considerations for generic transdermal
This presentation discussed in silico methodologies for topical products applied to the skin, with particular focus on dermal Dow Development Laboratories (DDL) emerges as a powerhouse, pushing the boundaries of topical drug product design and manufacturing.
The Role of Microstructure in Topical Drug Product Development' crosses over and is essential reading to developers of oral suspensions, ophthalmic ointments Product Quality Testing for Topical Ophthalmic Suspension Products (18of39) Complex Generics 2018 design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special
Product Dev Considerations for Generic Transdermal Delivery Systems (26of39) Complex Generics 2018 Patient-Centric Product Development Karu Sukuru, Catalent Pharma Solutions, Global Vice President, Rx Product Development. Best Practices for Topical Generic Product Development and ANDA Submission–Introduction & Session 1
Complex Generics: Complex Injectables, Ophthalmic, and Otic Products, Part 2 D2,S6,S2-Identification of Research Needs During Product Development Prior to ANDA Submission
FDA Advancing Generic Drug Development 2025: Recommendations for Topical and Mucosal Products Product Development Considerations for Generic Topical Products (22of39) Complex Generics 2018
Hirten Patel, PhD, Staff Fellow from the Division of Bioequivalence II (DB-II) presents the Practical Considerations Related to IVPT TITLE: Drug Development Company Commercialising Topical Products for Global Markets GUEST: Michael Kotsanis Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 2
PREVIEW: Topical Emulsions in the Pharmaceutical Industries | A 6 Hour Accredited Training Patient-Centric Product Development
Commissioner of Food and Drugs, Robert M. Califf MD, MACC, delivers his Keynote Address to the 2023 Advancing Generic Drug The process of developing a topical drug product can be broken down into several stages, each with its own set of challenges and considerations. Generic Development of Topical Dermatologic Products
This presentation described how ongoing research contributes to the evolution of Product-Specific Guidances (PSGs) for topical Subject: Pharmaceutical Science Paper: Product development Part 2. Product-Specific Guidances for Complex Generic Drugs
Sam Raney from the Division of Therapeutic Performance in CDER's Office of Generic Drugs discusses research activities. Best Products to Treat Cold Sores