Pharmaceutical Statistics

Bioequivalence & PK Statistics

Statistical design, analysis and reporting for BA/BE and pharmacokinetic studies.

• BA/BE study design and statistical analysis
• Average Bioequivalence (ABE)
• Reference-Scaled Average Bioequivalence (RSABE)
• Crossover, parallel and replicate-design studies
• PK parameter statistical analysis and treatment comparisons
• Geometric mean ratios and 90% confidence intervals
• Intra-subject variability and related statistical assessments
• Sample size and power calculations
• Descriptive statistics for PK parameters
• PK tables, listings and figures (TLFs)
• Plasma concentration–time summary tables
• Mean concentration–time profiles on linear and semi-logarithmic scales
• Individual concentration–time profiles, where required
• Statistical summaries for Cmax, AUC0–t/AUCt, AUC0–∞/AUCinf, Tmax, Kel, t½ and other protocol-specified PK parameters

Biopharmaceutics

Statistical evaluation of dissolution, particle-size and other in-vitro product-performance characteristics.

• Comparative dissolution profile analysis
• f1 difference factor and f2 similarity factor assessment
• Bootstrap f2 analysis, where applicable
• Dissolution profile comparisons across multiple strengths, media and time points
• Statistical evaluation of dissolution variability and product comparability
• Particle-size distribution analysis
• Population Bioequivalence (PBE) for particle-size distribution
• Statistical comparison of dissolution, particle-size and related in-vitro product-performance parameters
• Comparative statistical evaluation of protocol-specified product-performance characteristics
• Statistical support for biopharmaceutic and regulatory queries

Product Development Statistics

Statistical methods supporting formulation, CMC, product variability and development decisions.

• Stability data analysis and shelf-life estimation
• Statistical evaluation of formulation and batch comparisons
• Analytical method validation statistics
• Content uniformity and dose-uniformity statistical assessment
• Specification-setting and acceptance-criteria statistical support
• Statistical analysis of pharmaceutical product-development and CMC data
• Design of Experiments (DoE) and formulation optimization, where applicable
• Statistical evaluation of batch and product variability
• Sensitivity, supportive and additional statistical analyses for development and regulatory questions

Statistical Support for Abuse-Deterrence Evaluation

Specialized statistical support for comparative abuse-deterrence programs and regulatory review.

• Statistical planning for comparative abuse-deterrence evaluation programs
• Analysis of in-vitro manipulation and product-performance study data
• Comparative PK analyses for test and reference products, where applicable
• Test-versus-reference statistical assessments and protocol-specified comparisons
• Sensitivity, supportive and additional analyses for development and regulatory questions
• Statistical tables, figures, methodology and interpretation for submission packages and regulatory responses

Global Regulatory Statistical Support

Statistical analyses, documentation and response support for global regulatory submissions and review.

• Statistical analyses supporting global regulatory submissions
• Support for FDA, Health Canada, EMA, MHRA, PMDA and other applicable regulatory authorities
• Statistical support for generic-drug, pharmaceutical and clinical-development submissions
• Statistical input to regulatory submission planning and analysis strategy
• Statistical review of protocols and Statistical Analysis Plans (SAPs) for regulatory consistency
• Preparation and review of statistical methodology and report sections
• Submission-ready statistical analyses, tables, figures and supporting documentation
• Statistical justification of methods used for bioequivalence, PBE, dissolution/f2, stability and product-development analyses
• Support for regulatory authority questions, information requests and deficiency responses
• Additional, sensitivity, subgroup and supportive analyses requested during regulatory review
• Re-analysis and updated statistical outputs following regulatory authority feedback
• Statistical support for pre-submission and regulatory meeting packages, where required
• Cross-study or pooled statistical analyses, where applicable
• Independent statistical QC and reproducibility checks for regulatory deliverables