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Pharmaceuticals
96 topics across 7 chapters
Chapter 1
Drug & Biopharma Foundations
1
Chemistry & Biochemistry for Drugs
2
Human Physiology & Pathophysiology
3
Pharmacology Core Concepts
3 subtopics
4
Pharmacokinetics & Pharmacodynamics (PK/PD)
2 subtopics
5
PK/PD calculations practice (CL, Vd, t1/2, AUC)
6
Exposure–response interpretation (therapeutic window, Emax, toxicity)
7
Receptors & Signal Transduction
8
ADME & Metabolism Basics
9
Dosage Forms & Drug Delivery Basics
3 subtopics
10
Oral solid dosage forms basics (tablets/capsules)
11
Parenterals basics (injectables and sterility expectations)
12
Controlled release and delivery systems overview
13
Data Literacy for Pharma
3 subtopics
14
Descriptive statistics & data visualization for pharma
15
Clinical data standards basics (CDISC: SDTM/ADaM concepts)
16
Programming basics for analysis (Excel/SQL/Python orientation)
Chapter 2
Drug Discovery & Design
17
Target Identification & Validation
18
Hit Discovery (screening and early triage)
3 subtopics
19
Assay development fundamentals (controls, robustness, artifacts)
20
High-throughput screening (HTS) data triage basics
21
Fragment-based drug discovery (FBDD) overview
22
Lead Optimization (potency, selectivity, properties)
23
Medicinal Chemistry Workflow
24
Computational Drug Design
3 subtopics
25
Molecular docking basics (poses, scoring, validation)
26
QSAR modeling fundamentals (features, overfitting, validation)
27
Cheminformatics in Python with RDKit (hands-on molecules and fingerprints)
28
DMPK in Discovery (in vitro/in vivo property optimization)
Chapter 3
Nonclinical to Clinical Development
29
Preclinical Safety & Toxicology
3 subtopics
30
Safety pharmacology vs toxicology: core endpoints and interpretations
31
GLP study planning & reports (what ‘good’ looks like)
32
Translational biomarkers basics (fit-for-purpose, qualification vs validation)
33
Clinical Trial Phases & Design
5 subtopics
34
Phase I (first-in-human): SAD/MAD, safety, PK
35
Phase II: proof-of-concept, dose finding, endpoints
36
Phase III: pivotal trials, comparators, clinical meaningfulness
37
Phase IV: post-marketing commitments and effectiveness in practice
38
GCP essentials (protocol, monitoring, source data, essential docs)
39
Clinical Operations & Study Management
40
Biostatistics for Clinical Development
2 subtopics
41
Randomization, blinding, and sample size exercises
42
Interpreting p-values, confidence intervals, and multiplicity
43
CMC Development (formulation and process development)
Chapter 4
Regulation & Compliance
44
Regulatory Agencies & ICH Guidelines (FDA/EMA/PMDA; ICH Q/E/S)
45
GxP Overview (GLP, GCP, GMP)
3 subtopics
46
GLP essentials (roles, data integrity, audits, documentation)
↗ GCP essentials (protocol, monitoring, source data, essential docs) (see Chapter 3)
47
GMP essentials (quality culture, documentation, deviations, training)
48
Labeling & Promotional Compliance (claims, risk, fair balance)
49
Intellectual Property, Patents & Exclusivity
50
Ethics & Human Subjects Protection (IRB/IEC, consent, privacy basics)
Chapter 5
Manufacturing & Quality
51
GMP Manufacturing Operations
3 subtopics
↗ GMP essentials (quality culture, documentation, deviations, training) (see Chapter 4)
52
Unit operations overview (mixing, granulation, drying, filtration, filling)
53
Batch records and documentation practice (GDP habits)
54
Quality Management Systems (QMS)
4 subtopics
55
Deviations, investigations & CAPA
56
Change control & risk assessment (ICH Q9 mindset)
57
Audits & inspection readiness (findings, responses, remediation)
58
eQMS basics (requirements for TrackWise/Veeva-like systems)
59
Analytical Development & QC Testing
2 subtopics
60
Analytical method validation basics (accuracy, precision, specificity)
61
Stability testing basics (ICH conditions, OOS/OOT concepts)
62
Validation & Qualification
1 subtopics
63
IQ/OQ/PQ and process validation exercises (what evidence is expected)
64
Supply Chain, Cold Chain & Serialization
65
Sterile & Aseptic Processing (core concepts and failure modes)
66
Continuous Manufacturing & Process Analytical Technology (PAT)
Chapter 6
Clinical Use & Safety
67
Clinical Pharmacology & Dosing in Practice
68
Pharmacy Practice: Dispensing & Counseling Basics
69
Pharmacovigilance & Risk Management
3 subtopics
70
ICSR case processing basics (triage, coding, narratives, timelines)
71
Signal detection basics (disproportionality concepts and review workflow)
72
Risk minimization (REMS/RMP overview) and safety communications
73
Drug–Drug Interactions & Contraindications
74
Real-World Evidence & Pharmacoepidemiology
4 subtopics
75
Observational study designs (cohort, case-control, self-controlled)
76
Confounding, bias, and adjustment basics (matching, stratification, PS)
77
Real-world data sources (EHR, claims, registries) and data quality
↗ Descriptive statistics & data visualization for pharma (see Chapter 1)
78
Medication Adherence & Patient Education
Chapter 7
Business & Innovation in Pharma
79
Market Access, Reimbursement & Pricing
80
Commercial Strategy & Lifecycle Management
81
R&D Portfolio Strategy (risk, value, and prioritization)
82
Generics, Biosimilars & Competition
3 subtopics
83
ANDA and generic approval pathway basics
84
Bioequivalence study design overview (PK endpoints and comparators)
85
Biosimilar comparability & interchangeability overview
86
Partnerships, Licensing & Business Development
87
Medical Affairs & Evidence Generation
88
Global Health, Sustainability & Access to Medicines

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