We are looking for an exceptional PhD student to work on optimal designs for accelerated stability studies. The project is jointly between Lancaster University and Janssen: Pharmaceutical Companies of Johnson & Johnson and regular visits to the industry partner are expected and longer secondments are possible.
Funding:
Duration: 3.5 years
Stipend: £17500 per yearNo applications will be considered after 29 January 2017.
Other: £3000 per year (running costs/travel/conference allowance)
University full-time PhD Registration Fees at UK/EU rates
Start: around October 2017
Eligibility: UK/EU students are eligible to apply for the above funding
How to apply: Please send a cover letter and CV to t.jaki@lancaster.ac.uk
Deadline: Candidates are advised to apply as soon as possible as consideration of applications starts immediately, and the studentship will be offered to the first strong candidate who meets the requirements.
Entry requirements:
Strong performance on a masters degree in Statistics or a related field. Alternatively a very good degree (projected 1st class) in Statistics or related field.
Project description:
Stability studies evaluate a compound’s stability under the influence of a variety of environmental factors such as temperature, humidity and light. Traditionally these factors are set at typical levels (e.g. temperature 20⁰ C, 60% relative humidity and 30⁰ C, 75% relative humidity) which represent different climatic zones and cover potential markets that the drug product will be dispersed in. Changes in the compound are observed over long periods of time (1-2 years). The findings of these studies inform essential decisions such as recommended storage conditions and shelf lives in the different climatic zones intended for the drug product.
To obtain early insight into the compound, accelerated stability studies are conducted. These studies seek to explore the changes to the compound in a shorter time interval. To achieve a shorter observation time while still obtaining meaningful information, the compounds decomposition is accelerated by exposing the drug product to extreme/stress environmental conditions (e.g., 40⁰ C, 75% relative humidity, 50⁰ C, 50% relative humidity, 60⁰ C, 75% relative humidity, and 70⁰ C, 30% relative humidity).
Another important aspect of the accelerated stability studies is to allow for screening of multiple formulations of new drug products and selecting the most promising formulations in terms of chemical stability in a short time.
In this project we will consider the design of such studies and in particular consider optimal choice of timing of measurement and which level of the environmental factors should be used. In the first part we will explore optimal designs for a single objective (e.g. level of active pharmaceutical ingredient degradation) based on various kinetic models (zero, first and second order) before we expand to the framework to a setting with multiple endpoints of interest.
