Associate Professor
Dr Sabariah Noor binti Harun
PhD (2016) · University of Queensland, Australia
USM Expert CVPharmacometric Research Cluster · Universiti Sains Malaysia
Model-based decisions for better medicine in Malaysia.
S&S PRC@USM brings pharmacometrics - the science of modelling how drugs behave and how patients respond - into research, teaching and clinical practice, led by two principal investigators: Assoc Prof Dr Siti Maisharah Sheikh Ghadzi and Assoc Prof Dr Sabariah Noor Harun.
- Students in 2018
- 3
- Active postgraduates
- 15
- Pharmacometricians produced
- 5
- Featured publications
- 0
01 About
What is pharmacometrics?
Pharmacometrics uses mathematical and statistical models to describe how drugs behave in the body and how patients respond - turning scattered data into decisions about doses, trials and products.
Evidence
- Competitor label
- Pre-clinical data
- Safety trial
- Phase IIa trial
- Scientific literature
Normalise & fit
PK-PD model · dose–response
E = E0 + (Emax − E0) · C ⁄ (C + EC50)
Data normalisation and model fitting
Competitor labels, pre-clinical data, safety trials, Phase IIa trials and the scientific literature are brought together, normalised and fitted using pharmacometric methodology.
The result is a PK-PD model that links dose and drug concentration to response - the shape of the curve is what lets us predict beyond the data we have.
Inputs
- Competitor label
- Phase IIa trial
- Scientific literature
- Market study
- Trial operations
Decisions
What is the optimal trial design?
Should we develop a new dosage form?
What is the best regulatory strategy?
How should we position this product?
Models that answer real questions
- PK / PopPK
- PK / PD
- Meta-analysis
- Clinical utility
- Virtual clinical trials
- Decision analysis
Built on trial data, literature, competitor labels, market studies and trial operations, these models help answer:
- What is the optimal trial design?
- Should we develop a new dosage form?
- What is the best regulatory strategy?
- How should we position this product?
02 About
S&S PRC@USM objectives
-
Objective #1
To introduce pharmacometrics approach studies in Malaysia
-
Objective #2
To integrate model-based clinical decisions into clinical practice in Malaysia
-
Objective #3
To pioneer pharmacometrics advancements in Malaysia
-
Objective #4
To become a referral center for pharmacometrics consultation
04 Team
Our team
We have produced five pharmacometricians, and there are 15 active postgraduate students in our group. The group started with only three students in 2018 and has grown since.
Principal investigators
Associate Professor
Dr Siti Maisharah binti Sheikh Ghadzi
PhD (2017) · Uppsala University, Sweden
USM Expert CV05 Activities
S&S PRC@USM activities
Extensive pharmacometric workshops for students
Three editions, 2021 – 2025
06 Activities
Consultations
Pharmacometric-based consultation at national and international level - from attachments at our lab to virtual modelling advice.
07 Activities
Conferences & workshops
Pharmacometric-based talks, workshops and presentations at national and international level.
08 Activities
International collaborations
MOU activities - international collaboration in pharmacometric-based projects.
09 Outputs
Students’ achievements at international level
Travel grants, invited presentations and fellowships earned by our postgraduates at meetings across Asia, Europe, Australasia and North America.
10 Outputs
Pharmacometrics-related publications
Pharmacometrics-related papers by the S&S PRC@USM team, with full author list, first & corresponding author, and a direct link to each publication via its DOI.
11 PAGMAS
PAGMAS - Population Approach Group of Malaysia
Who are we?
- Founder
- A group of pharmacometricians from the academia, industry, consultancy sector and government sector in Malaysia.
- Registered
- Officially approved by the Registrar of Societies (ROS), Malaysia, as a registered, non-profit national society on 22nd February 2019.
PAGMAS objectives
- 1Promote the development and application of pharmacometrics in experimental, clinical, and regulatory settings in Malaysia.
- 2Offer a central organisation for the integration of pharmacometric communities in Malaysia.
- 3Connect pharmacometric communities in Malaysia to the international communities.
- 4Provide resources, mentoring, platform for scientific events, collaborative opportunities, and educational services to our members.
12 Contact
Let’s model it together.
For further details - supervision, workshops, consultations or collaboration - contact us at:
School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang
