Journey of a Drug: Design to Market Seller

Where do chemical drugs come from?  How will doctors know which medicine is good for which disease?  How can medicines actually cure a particular disease for which they are prescribed?  Do you have these questions every time you buy a medicine?

 Come, let us know about the development of medicine from the beginning…

 The development of medicine is called clinical research and has various stages.  Phases of clinical research are phases of experiments with health interventions in an attempt to find an evidence for a process that scientists believe will be useful in medical treatment.

 The drug study begins its journey from the design of a drug and the discovery of a drug molecule, which goes on to look at the effectiveness of the drug in further animal testing and then human studies.

 The drug undergoes several tests: preclinical, stage 0, stage I, II, III and IV.  Combination tests are sometimes performed to reduce development time, such as stages I / II and II / III.

 Preclinical study

 When a drug molecule is identified, it is subjected to several experiments in vitro (test tube or cell culture) and in vivo (animal).  These experiments are performed to ascertain the initial efficacy, toxicity, and pharmacokinetics of different doses of the drug.  Many drug molecules are designed at once, and these preclinical studies allow pharmaceutical companies to decide which molecule has the greatest potential in subsequent studies.

 Study Design:

 The tests are always performed after a set of steps, called a protocol, developed by researchers to find specific questions related to the medical product.  Information obtained from previous studies becomes the basis for researchers to develop questionnaires and research objectives:

 Selection of participants

 number of participants

 Period of study.

 Controlled or not

 How and what dose will be administered

 What and when data will be collected

 Time for review and analysis.

 Phase 0 study

 Also called microdosing trials, 10 to 15 human subjects are taken and given a single subtherapeutic dose to collect pharmacokinetic (PK) data of the drug.  This allows the company to decide whether to go for further development of the drug based on more relevant human data rather than animal data.

 Such testing exceeds the speed of promoting drug development by indicating whether the drug works in humans as expected in preclinical studies.

 After the company decided to take the drug molecule further in development, it referred data from its initial studies to the FDA called Investigational New Drug Application (IND).

 Phase I study

 They are also called first-human studies, as they are the first stage of human test studies.  These are studies designed to determine the maximum dose that can be administered without showing adverse effects.

 Contract Research Organizations (CROs) conduct such studies in clinical trial clinics where medical personnel provide full-time care to 2–100 healthy subjects enrolled and collecting data for the study.

 These studies determine drug safety (pharmacovigilance), tolerability, pharmacokinetics (PK) and pharmacodynamics (PD).  The design of the Phase I study is a series of doses called dose-escalation studies in controlled clinics called central pharmacological units (CPUs).

 Healthy subjects are usually recruited, but sometimes patients such as cancer and HIV are made ill and also those who have already tried to improve existing drugs.

 There are two departments for Phase I study:

 Phase Ia: Single Dose Ascending

 Phase Ib: multiple ascending doses

 Second stage study

 More than 100 sick subjects were enrolled in a long-term study, including genetic testing, to learn about its safety as well as the benefits of the drug.  These studies are also called "proof of concept or pilot" studies.

 This is the stage in which drug development may fail due to toxicity or lower than expected results.

 This phase has two divisions:

 Phase IIa: Pilot study to determine clinical efficacy or biological activity.

 Phase IIb: Dose discovery study to verify biological activity with minimal activity.

 A combined test that determines efficacy and toxicity are phase I / II tests.

 Phase III study

 These are pre-registration trials, meaning the data of this study is sent to the regulatory agency through the New Drug Application (NDA) for registration.  Also called premarket trial or fundamentals.

 These studies are multicolored, randomly, with a long duration of treatment in a large ill population (over 500) and a long follow-up period to determine the long-term safety and efficacy of the drug.

 If regulatory filing is pending, the drug is still received by patients if it is a life-saving drug until the drug can be purchased.

 The 'label extension' that is the drug may cure an additional disease, in addition to the disease for which the drug is already approved, may also be the reason for running a phase III trial.

 The FDA (United States Food and Drug Administration) and MHRA (UK Medicine and Health Products Regulatory Agency) are said to have required data from at least two trials from successful trials to register the drug.

 After these tests, the drug is approved for sale in the market.

 Phase IV study

 These are marketing safety monitoring studies conducted after the registration of the drug.  Which is also called late stage or confirmatory testing.

 This type of study determines long-term adverse effects over a long period (at least 2 years) in a very large population.  If harmful effects are detected in this study, the drug is rejected and the company has to retrieve the drug from the market because it can no longer be sold.

 The entire journey from molecule to drug takes about 15–20 years on one product in the market.

 The drugs must be sold, before going to market and without a prescription, go through a development route summarized in this article.  Drugs are just a molecule in a design or laboratory that a scientist has discovered during research.  In the laboratory, it undergoes several in vitro and in vivo tests that then progress through various stages of development based on the results shown by the drug molecule.  The drug has to pass through Phase I, Phase II, Phase III and after approval of Phase IV trials.  At any time if the expected results are not found or if side effects occur, the company will have to stop or halt all growth.  Or regulatory authority under which it should be or was approved.