Pharmacokinetics in special populations

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A perennial question within drug development is whether the same drug dose can be given across all sub-groups within a disease population. Is it enough to target the typical patient" A problem arises with this approach as the typical patient is difficult to define. In cardiovascular disease the patient population is skewed towards individuals over 45 years of age. Conversely asthma is common across all ages. At both ends of the age spectrum physiological processes such as hepatic and renal function differ to those of a healthy adult. An understanding of how these physiological changes affect the pharmacokinetics of a drug will aid the selection of the right dose for the right patients at the right time.

The aim of this course is -

To provide participants with the knowledge and understanding that will allow them to design and interpret the PK from studies in special populations.

What will participants gain -

Following the course attendees will have an understanding of how key pharmacokinetic parameters are affected by the physiological changes brought about during ageing and disease. Additionally they will have an overview of the design elements required in clinical studies of new medicines/formulations to allow the estimation of PK parameters in special populations

How will participants learn

Participants will learn through a mixture of formal lectures and learning in action workshops. The learning in action sessions are designed to complement and reinforce the formal teaching through individual and group exercises.

9.00am   Introduction

9.15     Influence of renal and hepatic impairment on Clearance and Volume

10.00   Workshop: case studies

10.30   Tea/coffee

11.00   PK Design considerations in hepatic/renal impairment studies

11.45   Workshop: case studies

12.30   Lunch

1.30    Clearance and Volume in children

2.30    Workshop: case studies

3.00    Tea/coffee

3.15    PK Design considerations in paediatric studies

4.00    Workshop: case studies

4.45    Concluding remarks

5.00pm   Close

Graham Blakey (Pharmacokinetics, Drug Development)

Graham had been investigating the clinical pharmacology of new drugs and novel formulations for over 20 years. He currently runs a consultancy company based in Nottingham that provides clinical pharmacology, PK and regulatory solutions to the pharmaceutical industry.

At AstraZeneca he was a Principal Scientist in Experimental Medicine, where he was involved in the transition of several new chemical entities from discovery into humans. He is experienced in a number of PK methodologies and has used these across the drug development spectrum, from pre-clinical through to late phase patient studies. Graham is an advocate of creative and efficient clinical study design and has applied these principles to many global drug development projects in several therapeutic areas. His skills have involved him in various patent cases where he has acted as an expert witness.

Graham has developed professional PK training courses for both experts and non-experts working in the pharmaceutical and bioscience sectors. Additionally, he has provided PK teaching on a number of undergraduate and postgraduate degree courses.

Graham holds a degree in Pharmacy and is a member of the Royal Pharmaceutical Society. He has an MSc in Clinical Pharmacology from the University of Glasgow and a PhD from the University of Manchester.

Hussain Mulla

Hussain Mulla is a graduate of Pharmacy from the University of Portsmouth (1992), and Clinical Pharmacy from the University of Derby (1996). He was awarded a PhD in Clinical Pharmacokinetics from De Montfort University in Leicester (2003). He was a senior clinical pharmacist in adult and paediatric intensive care (1996 to 2003) at Glenfield Hospital in Leicester.

Following completion of his doctorate (2003), he took a position at AstraZeneca in the Department of Experimental Medicine and Clinical Pharmacology. In 2006 Hussain returned to Glenfield Hospital, Leicester as a senior research pharmacist in paediatric clinical pharmacology. His research interests span applications of population pharmacokinetic/pharmacodynamic modelling, formulation development, safety and tolerability of excipients and microanalytical methodologies for facilitating paediatric pharmacokinetic/pharmacodynamic studies. Hussain has been the recipient (principle investigator) of an NIHR RfPB grant to investigate the bioavailability of unlicensed formulations, as well as industry funded and investigator led PK studies and is currently a collaborator in an MRC funded European project (ESNEE) to investigate the kinetics of excipients in formulation administered to neonates.

Participants should have a basic knowledge of pharmacokinetic concepts. The course would benefit individuals that have to design PK studies and either interpret or review the subsequent data generated. For example, clinical scientists, project pharmacokineticists, project directors, statisticians and clinicians.


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