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