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Formulation Changes and Bridging During Formulation Development – Part 2 Deepak Hegde
November 22, 2024
It focus on the real-life examples of bridging studies due to formulation changes from clinical study to commercialization of drug and real-life examples of bridging studies due to Reformulation (formulation changes) post commercialization of drug.
Formulation Changes and Bridging During Formulation Development – Part 1 Deepak Hegde
November 22, 2024
an outline of formulations change during development, details of the kind of Formulation changes from Phase 1 clinical study to commercialization of drug, Formulation changes Post-Approval and Commercialization.
Japanese Pharmaceutical Market & Registration Strategies- Part 2 Deepak Hegde
November 12, 2024
The second article in the series focuses on strategies for success in registering products on the Japanese market.
Japanese Pharmaceutical Market & Registration Strategies – Part 1 Deepak Hegde
November 12, 2024
The article provides an outline of characteristics、Regulatory bodies、 Pricing、Reimbursement、the process of registering an innovative drug and generic drugs in Japan.
Continuous Manufacturing Part 3: Continuous Manufacturing in China Deepak Hegde
February 05, 2024
This article, which is Part 3 and the concluding part of the series on continuous manufacturing focuses on CM in China and adoption of CM for biologic products.
Continuous Manufacturing Part 2: Challenges Open to CM Deepak Hegde
February 05, 2024
This article, which is Part 2 of the series on continuous manufacturing focuses on the challenges still open to CM after the publication of ICH Q13 Guidance document and how CM could contribute to in-shoring back to US.
Continuous Manufacturing Part 1: Changes in Global Regulatory Landscape Deepak Hegde
February 05, 2024
It's been about three years since I had written the three-part series of articles on Continuous Manufacturing (CM). Since then, a lot of water has flown under the bridge and there have been several developments in the field of CM. Now is probably the righ
Spray Drying: Addressing poor solubility and Bioavailability of drugs (Part II) Deepak Hegde
December 27, 2023
This article, which is Part 2 of the series on address some of the practical considerations in application of spray drying to later phases of development.
Spray Drying: Addressing poor solubility and Bioavailability of drugs (Part I) Deepak Hegde
December 13, 2023
Spray drying, an innovation in the development and manufacturing field has been gaining importance over the last few years, as an increasing number of drug products have been getting approved by regulators over the world and reaching the market. This seri
Formulation development of New chemical Entities (NCE’s) to commercialization Deepak Hegde
June 16, 2021
The process of taking a new drug from concept to clinic and eventually to commercialization involves several steps which traditionally occur in series.