A two-day course on technical report writing including:

• Organisation and structure
  • Planning the report
  • Accuracy, brevity and clarity
  • Report structure
• Style
  • Rules of style and grammar
  • Punctuation
  • SI unit abbreviations
• Graphical presentation of data
  • Presenting data clearly in tables and figures
  • Trend line and curve fitting
  • Error bars
  • Graphical representation of processes
• Statistical methods
  • Types of average
  • Statistical distributions
  • Deviations from normality
  • Outliers
  • Comparing means and variances
  • Evaluating linearity
• Practical sessions:
  • Identifying errors in report extracts
  • Designing tables and figures
  • Writing a report using model data

A three-day course on the theory and practice of dissolution testing including:

• Purposes of dissolution testing
• Dissolution theory, sink conditions and intrinsic dissolution rate
• Dissolution and drug release testing apparatus
• Requirements for different dosage forms (including data interpretation)
• Dissolution equipment qualification
• Dissolution method development including sampling time points and assay requirements
• Dissolution method validation
  • Setting method validation acceptance criteria with reference to drug product specifications
  • Specificity, linearity/range, accuracy/recovery, precision, robustness and solution stability
• Dissolution and the assessment of bioavailability/bioequivalence
• Practical sessions: setting up a dissolution tester with basket and paddle apparatus; performing a dissolution test on an immediate release drug product

This course will benefit anyone requiring an intensive introduction to dissolution testing and the associated procedures working in the following areas:

• Regulatory Affairs
• Pharmaceutical Development
• Analytical Development
• Project Management
• Quality Control
• Quality Assurance

After completing this course, trainees will understand dissolution theory, be familiar with the different types of pharmaceutical dissolution testing equipment, be able to adopt a logical, scientifically-sound approach to method development, understand the application if in vitro dissolution data in assessing bioequivalence, and be able to perform a dissolution test using USP 1 or 2 dissolution apparatus.