Drug Development Stages

We provide contract R&D services to our customers and partners in development of both new molecule entities or generic medicines. The development of a medicine is divided into two major stages:

Discovery Stage

In this stage, we identify diseases and conditions that lack effective treatments or have treatments with unwanted side effects or poor patient compliance. Next, we will screen and source for a chemical, protein, or gene that plays an important role in a particular disease. Our R&D Team will gather the chemicals that may interact with that targetby screening thousands of existing compounds to find suitable candidates, or by studying the structure of the target to develop a hypothesis about what a medicine for that target should look like. Next, we synthesize the small molecule (or biologic) to meet those criteria. We modified the molecule (or biologic) and asked many questions that eventually left with a few selected drug candidates for preclinical trials.

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Development Stage

Upon completion of the discovery stage, the next step is to evaluate its safety and efficacy. This marks the beginning of the development phase.

Preclinical Evaluation

In this stage, we conduct a variety preclinical tests to evaluate safety before human tests begin. The preclinical tests can be in vitro or in vivo (e.g. animals or cell lines).

Clinical Trials

If preclinical testing of a compound proves successful, it moves into clinical trials where teams of physicians and other clinical scientists conduct studies to determine if the medicine is safe in people and effective for the target disease. There are generally three phases of clinical trials:

  • Phase I
    This phase involves the first human tests in a small number of healthy volunteers to assess tolerability and potential dosing.
  • Phase II
    In this phase, a small group of volunteer patients who have the disease being studied are monitored in placebo-controlled trials. The goal is to establish the proof of concept or whether the medicine has the potential to positively impact the disease. Researchers continue to evaluate the drug’s safety and determine optimal dose strength and schedule.
  • Phase III
    The medicine is tested in large, randomized, placebo-controlled trials with larger numbers of patient volunteers to confirm the efficacy and safety profile by generating statistically significant data. Researchers further evaluate safety and efficacy and identify side effects.

The clinical trials from all of the development phases provide the data required to prepare submissions for regulatory approval to agencies around the world. The requirements for securing regulatory approval vary across different countries and geographic regions.

Following regulatory approval, clinical studies are conducted to support additional indications or new formulations as well as for post-marketing monitoring and research.