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This presentation provided an overview of the draft guidance on quality considerations for topical ophthalmic drug products. 2022 Topical Product Formulation Workshop Session 2 Presentations & Panel Discussion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