Drug Life Cycle & Regs
The strategic roadmap created early in development that defines the minimal and ideal goals of the product, such as indication, delivery mode, and safety standards
What is the Target Product Profile (TPP)?
The initial clinical trial phase conducted on 20–80 healthy volunteers primarily to evaluate safety, safe dosage range, and ADME pharmacokinetics
What is Phase I?
Any inactive substance added alongside the Active Pharmaceutical Ingredient (API) to form a dosage form
What is an excipient?
The manufacturing stage focused strictly on synthesizing or producing the bulk Active Pharmaceutical Ingredient (API)
What is Primary Manufacturing?
The modern production mode characterized by an uninterrupted, steady-state flow of materials from input to final product
What is Continuous Manufacturing (CM)?
he regulatory filing submitted to the FDA after pre-clinical testing to request permission to begin testing in human subjects
What is an Investigational New Drug (IND) Application?
The trial phase involving 100–300 target disease patients to establish preliminary drug efficacy and common short-term side effects
What is Phase II?
The primary reason why parenterals, implants, and eye drops must be manufactured in a 100% sterile and pyrogen-free state
Because they bypass the body's natural defense barriers (e.g. skin, gastrointestinal tract)?
The fundamental rule regarding the chemical structure of the API during secondary formulation processes
What is that the chemical structure remains unchanged?
The solid oral dosage form processing method that makes up the majority of commercially approved continuous manufacturing lines
What is Continuous Direct Compression?
The application submitted to regulatory authorities backed by GLP, GCP, and GMP evidence to gain authorization for commercial marketing
What is a New Drug Application (NDA)?
The trial phase testing 1,000–3,000 patients across up to 4 years to confirm overall clinical benefit and uncover rare side effects
What is Phase III?
A sterile, long-acting parenteral dosage form placed under the skin to continuously release API for months or years
What is an implant (or pellet)?
The primary manufacturing pathway that uses living biological cells to grow complex protein molecules like insulin
What is Biotechnology?
The three simple unit operations that comprise a basic continuous direct compression tablet line
What are loss-in-weight feeding, continuous mixing, and tablet compression?
he 7th phase of the drug life cycle, also known as Phase IV, where adverse drug reactions and defects are monitored post-launch
What is Post-Marketing Surveillance?
The four-letter acronym representing the pharmacokinetic parameters (Absorption, Distribution, Metabolism, Excretion) determined during trial screening
What is ADME?
The USP injectable classification for dry solids that must be reconstituted with water immediately before injection because the API hydrolyzes in liquid[20]
What is "For Injection"?
Partially processed materials generated when primary or secondary production is broken into multi-site stages[21]
What are Intermediates?
The regulatory framework that utilizes inline chemical and physical sensors to monitor critical quality attributes during processing
What is Process Analytical Technology (PAT)?
The total number of years an innovator company receives patent protection over a new drug molecule from the date of application
What is 20 years in the context of drug life cycle?
The life-threatening immunological reaction that hospitalized all six healthy male volunteers during the 2006 Phase I trial for TGN1412
What is a cytokine storm (or cytokine release syndrome)?
The eye tissue structure that connects directly to the central nervous system, making unsterile ophthalmic products a severe health hazard
What is the conjunctiva / conjunctival sac?
Name three secondary manufacturing unit operations used in solid dosage form processing
What are milling, blending, granulation, tablet compression, coating, or encapsulation?
The International Council for Harmonisation (ICH) quality guidance document created specifically to cover continuous manufacturing
What is ICH Q13?