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Adhere to global regulatory norms and offer end-to-end support to ensure quality compliance across all phases of clinical development.
The continuum of drug development is a fascinating interplay of scientific innovation and rigorous validation. It all begins with drug discovery, a phase characterized by extensive research to identify novel molecules or biologics that could potentially treat diseases. Once a promising candidate emerges, it enters the preclinical stage.
Preclinical studies in new drug development are absolutely vital. Conducted in laboratories and using animal models animal models following OECD Principles of Good Laboratory Practice (GLP)., these studies are designed to evaluate safety and pharmacology under Quality & Compliance and Regulatory Affairs standards:
The insights gleaned from preclinical studies are critical for determining whether a compound is safe enough and sufficiently promising to move forward into human testing. It’s the critical bridge that validates the potential of a new therapy before it ever reaches a human volunteer.
Once a compound successfully clears preclinical studies, it enters clinical drug development, a highly structured series of phases involving human participants:
This initial phase of clinical drug development involves a small group of healthy volunteers or patients. The primary goal is to assess the drug’s safety, determine a safe dosage range, and study how the drug is absorbed, metabolized, and excreted by the body (pharmacokinetics).
In Phase II, the drug is administered to a larger group of patients who have the disease or condition the drug is intended to treat. The focus shifts to evaluating the drug’s effectiveness, further assessing safety, and determining the optimal dosage and treatment regimen.
Phase III trials are large-scale, often multi-center studies involving hundreds to thousands of patients. The primary objective is to confirm the drug’s efficacy, monitor adverse reactions, and compare it to existing treatments or a placebo. Successful completion of Phase III trials is typically required for regulatory approval. These large-scale studies represent the most resource-intensive phase of Clinical Development, confirming both efficacy and safety.
Even after a drug is approved and marketed, clinical drug development continues with Phase IV studies. These involve ongoing surveillance to monitor the drug’s long-term safety and effectiveness in diverse populations, and to identify any rare or long-term side effects.
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Streamline Your Drug Development with Curexbio CRO Expertise
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