Applying physiochemical analysis techniques during drug product development

Reducing risks

Date: 12th -13th August 2019

Event Type: Seminar

The pharmaceutical industry must release new and generic products to the market as quickly and cost-effectively as possible. This is to provide or maintain access to vital therapies whilst enabling healthcare providers to manage their costs. Fundamental to the acceleration of the drug development process is the application of improved analytics to aid API and formulation selection.

During the workshop, which took place in Hyderabad and Ahmedabad,  academics and industry key opinion leaders gave lectures alongside Malvern Panalytical’s application specialists. They shared their experience of the use of morphological, structural and elemental analysis in support of rapid generic pharmaceutical product development. They discussed regulatory advice relating to API characterization, aligned with ICH Q6A and Q3D, as well as providing guidance concerning both deformulation and in vitro bioequivalence assessment. Case studies which highlighted the use of complementary analytical techniques to achieve better formulation understanding were also presented.
Training and consultation sessions were also conducted by Malvern Panalytical’s application specialists. This included training in the use of advanced compound indexing methods for XRD solid form analysis. This support enabled many participants to obtain specific feedback on analytical challenges that they were facing.

Presentation Material:

API Development - Purity and Stability (Dr Michael Caves)

Applying IVBE approaches to nano-drug delivery formulations (Dr Anand Tadas)

Deformulation and in vitro bioequivalence testing - What approaches can be applied for assessing bioequivalencein vitro for OINDP and OSD products? (Dr Paul Kippax)

Method Selection - How does understanding ‘why’ measurements are made affect the process of analytical method development? (Dr Paul Kippax)

Solid Form Analysis (Dr Umesh Tiwari)

XRF - A potent tool for impurity analysis and much more… (Dr Michael Caves)