Formulation Changes and Bridging During Formulation Development – Part 2
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.
November 22, 2024
by Deepak Hegde
Formulation Changes and Bridging During Formulation Development – Part 1
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.
November 22, 2024
by Deepak Hegde
Japanese Pharmaceutical Market & Registration Strategies- Part 2
The second article in the series focuses on strategies for success in registering products on the Japanese market.
November 12, 2024
by Deepak Hegde
Japanese Pharmaceutical Market & Registration Strategies – Part 1
The article provides an outline of characteristics、Regulatory bodies、 Pricing、Reimbursement、the process of registering an innovative drug and generic drugs in Japan.
November 12, 2024
by Deepak Hegde
Continuous Manufacturing Part 3: Continuous Manufacturing in China
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.
February 5, 2024
by Deepak Hegde
Continuous Manufacturing Part 1: Changes in Global Regulatory Landscape
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
February 5, 2024
by Deepak Hegde
Continuous Manufacturing Part 2: Challenges Open to CM
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.
February 5, 2024
by Deepak Hegde
Spray Drying: Addressing poor solubility and Bioavailability of drugs (Part II)
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.
December 27, 2023
by Deepak Hegde
Spray Drying: Addressing poor solubility and Bioavailability of drugs (Part I)
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
December 13, 2023
by Deepak Hegde
Formulation development of New chemical Entities (NCE’s) to commercialization
The process of taking a new drug from concept to clinic and eventually to commercialization involves several steps which traditionally occur in series.
June 16, 2021
by Deepak Hegde
Continuous Manufacturing Part 3: Batch Size And Control Strategies
This paper shows the definition of batch in continuous manufacturing, its importance from a regulatory perspective.
May 18, 2021
by Deepak Hegde
Continuous Manufacturing Part 2: Industrial Adoption of Continuous Pharmaceutical Manufacturing
This article, which is Part 2 of the series on continuous manufacturing focuses on the uptake of continuous manufacturing by the pharmaceutical industry for both API and drug products, scaleup to pilot scale and successes in commercialization.
May 10, 2021
by Deepak Hegde