Research And Development
Leckie Pharma UK is specialized in product development and filing at international regulatory bodies like the USFDA and UK MHRA.
The new molecules filing includes a preclinical trial on non-human subjects and 4 other clinical trials as follows:
- Phase I clinical trials typically are conducted with a small number of healthy volunteers, typically fewer than 100, to determine the safety, tolerability, and pharmacokinetics, and pharmacodynamics of the potential drug.
- Phase II clinical trials begin if the drug successfully passes Phase I testing. This phase generally involves between 100 and 500 participants to assess the efficacy of the drug.
- Phase III clinical trials are initiated if the potential new medicine is found to be both safe and efficacious through Phases I and II testing. Phase III trials may enroll 1,000 to 5,000 patients or more across numerous clinical trials sites across states and around the world. These randomized, controlled trials generate large amounts of data to support submission to the FDA for approval.
- FDA regulatory review and approval involves the submission of the data collected from
- Phase IV involves post-marketing pharmacovigilance monitoring.
The Generic molecule
Leckie Pharma UK follows the Hatch-Waxman by which we apply the abbreviated new drug applications (ANDAs), which permits generic pharmaceutical manufacturers to build on FDA’s prior approval of the brand drug with the same ingredients to establish the safety and efficacy of their generics. a bioequivalent study between the generic and the brand originator product demonstrating that both drugs have the same pharmacokinetic (absorption, distribution, metabolism, and excretion) properties inside the human body. In addition, ANDA requires generic proposed labeling to be identical to the originator labeling except for manufacturing information or other changes that have been approved and added.