Technical Project Management for Generic Drug Development

Explains active pharmaceutical ingredients (API) and finished pharmaceutical products (FPP), clarifying API versus inactive ingredients and outlining generic and reference drug development steps and dosage form types.

Define reference listed drugs and comparators, explain interchangeability with generics, and show how identical efficacy, safety, and quality are demonstrated via in vitro and in vivo studies.

Learn how pharmaceutical bioequivalence and therapeutic equivalence underpin generic drug development by proving similar efficacy, safety, and quality through bioequivalence studies and pharmacokinetic metrics like Cmax, Tmax, and AUC.

Understand the reference listed drug development process from basic research and non-clinical studies through clinical trials, NDA filings with the FDA, and post-market launch.

Discover the phases of generic drug development, including characterizing the reference drug, aligning in vitro and in vivo with the RLD, and preparing the CTD dossier for approval.

Explore the timeline and patent considerations shaping reference listed drug development and generic drug strategies, including discovery, indications, formulation patents, and bioequivalence dossiers.

Explore in vitro and in vivo dissolution studies for solid oral dosage forms within CTD modules four and five, highlighting dissolution data, bioavailability, and quality control in generic drug development.

Define a project as a temporary process for generic drug development and balance time, cost, and scope across one molecule, one dosage form, and the steps from research to launch.

Prioritize projects to build a pipeline by selecting molecules based on patent expiration, market need, and costs, while evaluating technology feasibility and GMP fit with facilities.

Define the project life cycle for generic drug development, detailing initiation, planning, execution, monitoring and control, and closure, with a kickoff meeting, Gantt charts, and milestones.

Discover the project manager's role in technical drug development, detailing responsibilities, goals, time and cost constraints, and essential skills and tools like experience, knowledge, communication, discuss, negotiate, and focus.

Explore how the project team and stakeholders coordinate across R&D, formulation, analytical, and CMC, along with business development, regulatory affairs, QA/QC, project management, and IP in generic drug development.

Explore essential project management tools, including project diaries, Gantt charts, diagrams, milestones, and budgets, to track actions, timelines, and owners in generic drug development.

Use a project diary as a daily tracking tool to record action owners and deadlines, monitor progress, and surface open points for discussion with responsible persons.

Map project milestones along the generic drug development timeline, highlighting checkpoints for raw material selection, pre-formulation studies, formulation studies, pilot manufacturing, and bioequivalence with a Gantt chart.

This lecture explains project Gantt charts as a bar chart tool for planning and tracking generic drug development tasks, showing activities, timelines, start and end weeks, and duration.

Explore the sequence of generic drug development phases, from task research and raw material selection through pre-formulation, unethical method development studies, formulation, pilot manufacturing, bioequivalence, registration dossier, and launch.

Conduct desk research for generic drug development through literature searches and patent restriction assessments. Explore drug names, characteristics, and generics using project management tools like diaries and Gantt charts.

Explore how to navigate the European Medicines Agency site to extract reference listed drug details, including dapagliflozin's authorization, dosage, and excipient information for generic drug development.

Explore WHO and FDA guidance for generic drug development, using dapagliflozin to examine prescribing information, drug interactions, safety data, and bioequivalence study design with in vitro considerations.

Leverage pharmacopoeias and DailyMed for desk research in generic drug development. Access EMA and FDA prescribing information, packaging, NDC codes, and other drug data via official resources.

Explore how Drugs.com supports generic drug development research by illustrating dapagliflozin drug product information, dosing, side effects, interactions, storage, and the mobile app.

Access DrugBank online to learn dapagliflozin pharmacology, including absorption, 78% oral bioavailability, 1 hour t max, half-life, drug interactions, ATC codes, CAS, IUPAC, pharmacoeconomics, and MSDS for generic drug development.

Explore pattern search on Google Patents to identify originator patents for dapagliflozin and metformin, focusing on composition, immediate release tablet formulations, and claims.

Explore Espacenet and the European Patent Office resources to conduct advanced patent searches for generic drug development, including querying dapagliflozin, originator, composition, and claims.

Focuses on raw material selection for generic drug development, covering API characteristics, API stability, supplier evaluation, and inactive ingredient and packaging material evaluation.

Evaluate API characteristics for raw material selection, including salt vs base forms, solubility, stability, polymorphs, and related substances and residual solvents to influence in vitro and in vivo profiles.

Assess API stability and drug product stability in generic drug development, focusing on physical, chemical, and polymorphic stability, including salt to base transitions, to support shelf life.

Assess API and API supplier quality requirements during the raw material selection phase, ensuring DMF availability, GMP-certified drug substance manufacturing, a certificate of suitability, and complete quality documentation.

Evaluate inactive ingredients and packaging materials by verifying GMP, certificate of analysis, and supplier checklists; assess performance, stability, and compatibility with the drug substance, shelf life, and IP considerations.

Explore formulation studies within pre-formulation for generic drug development, covering drug characterization, quality definitions, target product profile, equivalency, inactive ingredients, compatibility, and pre-formulation trials.

Characterization of the reference drug (RLD) establishes similar chemical and physical characteristics in vitro and in vivo to support generic drug approval, guiding pre-formulation and development strategy.

Define quality target product profile (QTPP) as a prospective summary of finished drug quality, linking safety, efficacy, and characteristics to guide pre-formulation, with CMAs, CPPs, and CQAs shaping the target.

Explain evaluation of bioequivalence requirements for generic drugs using in vitro dissolution data and waivers to reduce in vivo studies, guided by the guideline on the Investigation of Equivalency.

Evaluate inactive ingredients in pre-formulation studies to optimize the generic drug product formulation, considering functional characteristics, particle size, viscosity, price, quality, and supplier quality for registration specifications.

Explore compatibility studies in pre-formulation to predict stability and degradation of drug products by testing API and excipients under humidity, compression, temperature, peroxides, and UV conditions, including fixed-dose combinations.

Identify and supply needed ingredients, equipment, and apparatus during the generic drug development formulation phase, ensuring quality requirements, qualification and calibration, and early sourcing to save time.

Explore pre-formulation trials in generic drug development by evaluating API and raw material compatibility, performing assay and dissolution profile analyses, and shaping formulation and process strategy for shelf life characteristics.

Analyze phases of generic drug development, focusing on unethical method development studies and the roles of qualitative and quantitative analyses in raw material and drug product testing.

Explore analytical method development for generic drug development, including literature search, supplying chemicals, materials and equipment, method development steps, acceptance criteria, solution parameters, stress testing, and validation.

Develop analytical methods for raw materials and drug products with a strong chemistry background, using literature searches, EP and USP pharmacopoeias, and drug master files.

Coordinate supply of chemicals, materials, and equipment for analytical method development and unethical method development, including HPLC columns and GCC systems, and record the drug product from genetic development studies.

This lecture explains the role of sampling procedures and analytical techniques in pharma quality control for raw materials and drug products, emphasizing ethical, accurate sampling and subsequent analysis methods.

Define acceptance criteria for raw materials and drug product analyses in pharma, guided by official guidelines and pharmacopoeia monographs; apply supplier specifications and core certificates of analysis.

Develop in vitro dissolution methods for solid oral generic drugs and define selective parameters for our solution method to support in vivo solubility, permeability, and analytical method development.

Learn how to perform stress studies to develop stability-indicating analytical methods, simulate shelf-life conditions, and observe degradation products to strengthen quality control for drug products.

Perform pre-validation studies to confirm an RNA analytical method is capable for formulation development, applying specificity, accuracy, precision, intermediate precision, repeatability, detection and quantitation limits, and linearity.

Explore formulation studies in the generic drug development project phases, including formulation trials, optimization, pilot manufacturing, and compatibility studies for final formulations and critical quality attributes.

Develop and test drug formulations through systematic trials to achieve ideal in vitro and in vivo performance and stability, using ingredients, tools, and specifications for generic drug products.

Apply quality by design to optimize drug product composition and process parameters, define quality target product profile, CMAs and CPPs, and establish design space and control strategy via direct compression.

Organize supplying of chemicals, raw materials, and equipment early in the project to support formulation development and pilot manufacturing process, ensuring materials are ready for autopilot manufacturing and time management.

Define critical material attributes within a quality by design framework and illustrate how these attributes shape drug product performance in direct compression, including particle size and solubility.

Apply quality by design to define critical quality attributes for drug product, illustrated through direct compression, highlighting critical material attributes and critical process parameters for homogeneous, flowable, and compressible powder.

Define critical process parameters in quality by design and show how direct compression uses mixing speed, mixing time, container filling ratio, and dilution addition to affect homogeneity and content uniformity.

Develop selective dissolution methods and discriminative parameters using basket or paddle apparatus at 50–75 rpm to compare reference and generic drug products in vitro and assess similarity with f2.

Explore compatibility studies to forecast stability and shelf-life degradation. Assess final formula and manufacturing method with excipients, apis, stress conditions (humidity, temperature, peroxide, ultraviolet) and fixed-dose compatibility.

Explore analytical studies and unethical studies in generic drug development, including method development and validation, bulk and product evaluation, and in vitro dissolution under formulation and process parameter variations.