Clinical Analytics & Biostatistics5 Structured Units

Clinical Data Analytics & Biostatistics

Statistical pharmacology, clinical trial data manipulation, bioequivalence testing, and pharmaceutical quality control analytics.

Unit IUpcoming Curriculum

Pharmaceutical Biostatistics Fundamentals

Descriptive statistics, normal distribution, hypothesis testing, p-values, Student's t-tests, and Chi-square analysis applied to clinical and formulation datasets.

Planned Topics:

Measures of Central Tendency & Dispersion

Parametric vs Non-Parametric Tests

Confidence Intervals & Standard Error

Formulation Variance & Sampling Techniques

Unit NotesContent in Roadmap

Unit syllabus defined; full notes will be populated as curriculum advances.

Unit IIUpcoming Curriculum

Clinical Trial Data Handling with Pandas & Python

Cleaning, transforming, and aggregating patient clinical records, multi-arm clinical trial datasets, adverse event reporting, and demographic stratification.

Planned Topics:

Data Wrangling with Pandas

Cleaning Missing Lab & Patient Values

Merging Multi-Center Clinical Datasets

Adverse Event Frequency Analysis

Unit NotesContent in Roadmap

Unit syllabus defined; full notes will be populated as curriculum advances.

Unit IIIUpcoming Curriculum

Bioequivalence, Bioavailability & Pharmacokinetics

Statistical assessment of bioequivalence (90% Confidence Interval of geometric mean ratios), non-compartmental analysis (NCA), and Cmax/AUC bioequivalence criteria.

Planned Topics:

Bioequivalence Study Design (2x2 Crossover)

Geometric Mean Ratios & Log Transformation

90% Confidence Interval Guidelines (FDA/EMA)

Non-Compartmental Analysis (NCA) with Python

Unit NotesContent in Roadmap

Unit syllabus defined; full notes will be populated as curriculum advances.

Unit IVUpcoming Curriculum

Dissolution Profile Comparison (f1 & f2 Factors)

Mathematical computation of Difference Factor (f1) and Similarity Factor (f2) for in vitro dissolution profile matching, Weibull model fitting, and batch-to-batch consistency.

Planned Topics:

Calculation of f1 (Difference) & f2 (Similarity)

Regulatory Criteria for Dissolution Equivalence

Kinetic Model Fitting (Zero Order, First Order, Higuchi, Korsmeyer-Peppas)

Automated Dissolution Scripting

Unit NotesContent in Roadmap

Unit syllabus defined; full notes will be populated as curriculum advances.

Unit VUpcoming Curriculum

Statistical Quality Control (SQC) & Process Validation

Control charts (X-bar, R-charts), process capability index (Cpk, Ppk), assay limits, and batch failure analysis in industrial pharmaceutical manufacturing.

Planned Topics:

Shewhart Control Charts in Pharma QC

Process Capability Metrics (Cp, Cpk)

Assay Limits & Out of Specification (OOS) Analytics

Automated QC Dashboard Generation

Unit NotesContent in Roadmap

Unit syllabus defined; full notes will be populated as curriculum advances.