Knowra Drug development Drug development Drug development is the process of discovering, testing, manufacturing, and seeking approval for new medicines. It combines laboratory research, clinical trials, regulatory review, and preparation for use.
Target identification : The process of selecting a biological molecule or pathway whose modification may treat a disease. It defines the biological problem a new medicine is designed to address.
Pharmacology : The study of how drugs interact with living organisms and how organisms respond to them. It supplies core concepts for predicting a candidate’s effects and risks.
Biologic drug : A medicine produced from or containing biological sources, such as proteins, cells, or nucleic acids. Biologics often require specialized development, testing, and manufacturing methods.
Generic drug : A medicine equivalent to an approved brand-name drug in active ingredient, strength, dosage form, and route of administration. Generic medicines generally rely on equivalence evidence rather than repeating full originator development.
Informed consent : A process in which a person receives relevant information and voluntarily agrees to participate in research or treatment. Clinical development depends on voluntary participation under ethically meaningful consent.
Drug discovery : The search for compounds or other interventions that can produce a desired biological effect. It generates and evaluates candidate medicines before formal development begins.
Pharmacokinetics : The study of how a substance is absorbed, distributed, metabolized, and eliminated by the body. These measurements help determine dosing and interpret exposure in development studies.
Vaccine : A biological preparation that trains the immune system to recognize a pathogen or other target. Vaccine development evaluates immune responses and protection, not only treatment of existing disease.
Biosimilar : A biological medicine shown to be highly similar to an already approved reference biologic, with no clinically meaningful differences. Biosimilar development compares a product with an existing biologic rather than starting from an unapproved candidate.
Institutional review board : An independent committee that reviews research involving human participants to protect their rights and welfare. Its oversight helps ensure trials meet ethical requirements before and during enrollment.
Show all 27