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 this workshop, we have invited Indian academics and industry key opinion leaders to guest lecture alongide Malvern Panalytical’s application specialists. They will share their experience of the use of morphological, structural and elemental analysis in support of rapid generic pharmaceutical product development. They will discuss regulatory advice relating to API characterization, aligned with ICH Q6A and Q3D, as well as guidance concerning both deformulation and in vitro bioequivalence assessment. Case studies which highlight the use of complementary analytical techniques to achieve better formulation understanding will also be presented.
Alongside our workshop program, Malvern Panalytical is offering training and consultation opportunities, led by our applications team. This includes training in the use of advanced compound indexing methods for XRD solid form analysis. This support will enable you to obtain specific feedback on analytical challenges you are facing, as they relate to our products and solutions. **Please book your preferred time slot with Melissa.email@example.com**
This workshop will also be conducted in Ahmedabad on Mon - Tue, 12-13 Aug.
August 08 2019 - August 09 2019
09:00 - 17:00
Hyderabad, Andhra Pradesh, IN-AP, India
Day 1, Thur 8 August morning, API characterisation and development
09:15 API characterization: why is it required and what critical material attributes should be considered?
09:45 Solid form analysis: developing failproof methods for polymorph identification and detection
10:30 Tea break
10:45 Morphological analysis: what does it enable us to understand and how can it be achieved?
11:30 Elemental Analysis: what is required and how does USP+lt;735>enable more rapid screening for elemental impurities?
12:00 Instrument demonstration
Day 1 afternoon: Drug product formulation characterization and development
13:45 De-formulation and IVBE: what approaches can be applied for assessing bioequivalence in-vitro and how are these applied for Oral Solid Dose products?
14:30 Case study: applying IVBE to Orally-Inhaled and Nasal Drug Products (OINDPs)
14:50 Tea break
15:10 Case study: applying IVBE approaches to nano-drug delivery formulations
15:40 Case study: applying IVBE to topical formulations
16:00 Method selection: how does understanding ‘why’ measurements are made affect the process of analytical method development?
16:30 Instrument demonstration
Day 2, Fri, 9th August morning: Hands-on software training using HighScore
09:00 Hands-on training (please bring your laptop)
- Indexing for pharmaceutical analysis
- Bitmap converter
10:30 Tea break
10:45 Hands-on training (continued)
Afternoon: One-on-one consultation sessions with our applications team **Please book your preferred time slot with Melissa.firstname.lastname@example.org**
13:00 Meeting slot 1
14:00 Meeting slot 2
15:00 Tea break
15:15 Meeting slot 3
16:15 Meeting slot 4