L-2 Drug Design, Testing, Manufacturing and Market PDF

L-2 Drug Design, Testing, Manufacturing and Marketing Dr. Salma Naqvi Asst. Prof., Pharmacology GMU, Ajman Learning objectives Name several ways in which drugs are discovered or created. Differentiate between the chemical, generic, and t...

L-2 Drug Design, Testing, Manufacturing and Marketing Dr. Salma Naqvi Asst. Prof., Pharmacology GMU, Ajman Learning objectives Name several ways in which drugs are discovered or created. Differentiate between the chemical, generic, and trade/brand names of a drug. List at least five things that the trade names of drugs might tell you about those drugs. What do you understand by the ‘Drug Patent’? Explain National Drug Code (NDC). Give four reasons why a drug might be withdrawn from the market or recalled.  Drug Design Time consuming and expensive process; thousands of chemicals evaluated before receiving FDA approval. Drug discovery and design requires the identification of candidates, synthesis, characterization, screening, and assays for therapeutic efficacy. 1. Research & early development Try to understand the underlying mechanism or cause of a certain disease New chemical or molecular entities that display promising activity against a particular biological target thought to be important for the disease. 2. Preclinical research Goal of preclinical study is to determine a product’s ultimate safety profile Products may be new or iterated medical devices, drugs and gene therapy solutions For instance, drugs may undergo pharmacodynamic, pharmacokinetic, ADME, and toxicity testing through animal testing ,both in vitro and in vivo tests will be performed. 3. Chemical & pharmaceutical development Aim is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product Support the establishment of the design space, specifications, and manufacturing controls. 4. Clinical research Collect safety and efficacy data for new drugs These trials can only take place once there is adequate information about the quality of the product, its non-clinical safety and once health authority approval has been granted After conclusion of the clinical trials the drug will be submitted for regulatory approval, 5. Chemical & pharmaceutical production Once a new drug has been approved by the regulatory agencies such as the Food and Drug Administration in the US a full scale manufacturing plant will be built based on the scientific understanding gathered during the chemical and pharmaceutical development phase.  Drug Testing In vitro testing – done in laboratory in glass tubes and Petri dishes In vivo testing – carried out in living humans and animals Placebo A placebo is anything that seems to be a "real" medical treatment but isn't. It could be a pill, a shot, or some other type of "fake" treatment. They do not contain an active substance meant to affect health. Isomer Each of two or more compounds with the same formula but a different arrangement of atoms in the molecule and different properties.  Drug Manufacturing The FDA carefully monitors the quality of both generic and trade name drugs manufactured by all drug companies. Generic and related trade name drugs must contain exactly same active drug ingredients Must be administered in exactly the same way Variations among manufacturers are permitted for a. Inert ingredients (fillers and binders) b. Preservatives c. Antioxidants d. Buffers Once approved by FDA manufacturer cannot change a. Ingredients b. Manufacturing process c. Labeling d. Packaging e. Dosage  Packaging The manufacturing process also includes securing the drug in an appropriate container. Tamper-evident containers Amber glass containers Blister packs Sealed containers Child-resistant containers  Drug Marketing The advertising of over-the-counter drugs is regulated by the Federal Trade Commission. The advertising of prescription drugs is regulated by the FDA based on the federal Food, Drug, and Cosmetic Act. For many years, drug companies only promoted their prescription drugs by advertising to physicians in the form of visits from a drug sales representative, free samples, promotional literature and videos, and advertising in medical journals. This is still the most prevalent form of prescription drug advertising. Now, however, direct-to-consumer marketing has become common, with magazine ads and television.  Drug Patents The trade name of a drug is registered with the U.S. Patent Office as a registered trademark. While the drug remains under patent, only the original drug company has the right to advertise and market the drug under that trade name. A drug company is protected by a 17-year patent on any new drug that is approved by the FDA. This means that, during those 17 years, no other company can manufacture or market an identical drug. However, when the patent expires, any other drug company can manufacture that drug under its original generic name or under a new trade name and compete for a place in the market. The drug’s original trade name can only be used by the original drug company. If a generic drug is manufactured by several different drug companies, it will be listed under several different trade names.  National Drug Code (NDC) NDC: A multi-digit, unique identifier number of the drugs. The NDC is given in three segments. First segment: identifies the drug company (this part of the number is assigned by the FDA) Second segment: identifies the drug’s specific strength/dose Third segment: is a package code that identifies the package size and type. Phases of the human testing of new drugs Phase 0 trials These studies aim to find out if a drug behaves in the way researchers expect it to from their laboratory studies. Usually only involve a small number of people and they only have a very small dose of a drug. How the drug behaves in the body How abnormal cells in the body respond to the drug The main aim of these studies is to speed up the development of promising new drugs. Phase 1 trials How much of the drug is safe to give What the side effects are How the body copes with the drug If the treatment shows a positive effects The first few patients to take part (called a cohort or group) are given a very small dose of the drug. If all goes well, the next group have a slightly higher dose. The dose is gradually increased with each group. The researchers monitor the effect of the drug until they find the best dose to give. This is called a dose escalation study. Phase 2 trials If the new treatment works well enough to test in a larger phase 3 trial Which types of cancer the treatment works for More about side effects and how to manage them More about the best dose to use There may be up to 100 or so people taking part Sometimes in a phase 2 trial, a new treatment is compared with another treatment already in use, or with a dummy drug (placebo). If the results of phase 2 trials show that a new treatment may be as good as existing treatment, or better, it then moves into phase 3. Phase 3 trials These trials compare new treatments with the best currently available treatment (the standard treatment) A completely new treatment with the standard treatment Different doses or ways of giving a standard treatment A new way of giving treatment with the standard way Phase 4 trials Phase 4 trials are done after a drug has been shown to work and has been granted a license. More about the side effects and safety of the drug What the long term risks and benefits are How well the drug works when it’s used more widely Reasons for Pulling a Drug From the Market When a drug is discovered to pose a health risk to patients after reaching the market, a recall may ensue. Manufacturers and the FDA make recall decisions on a case-by-case basis for individual drugs. However, there are some common reasons for issuing a recall:(post-marketing surveillance) Risk of Health Problems - Sometimes further study reveals a connection between taking a drug and a potential health problem. Some pharmaceutical drugs have been linked to an increased risk of heart attack, stroke, kidney failure, and other serious complications. Previously Unknown Drug Interactions - Mixing drugs can cause health problems. Sometimes a drug may be discovered to cause problems when taken with another drug, a certain type of vitamin, or certain foods. Manufacturing and Packaging Errors - Sometimes a problem at the factory will require a recall. A contamination problem may make a drug unsafe for consumption, or a packaging error may unseal a drug before it reaches the patient.