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Edit Comment Close Premium member Presentation Transcript THE NEW DRUG APPROVAL PROCESS AND CLINICAL TRIALS: THE NEW DRUG APPROVAL PROCESS AND CLINICAL TRIALS By Kasturi Panda M.Pharm(Pharma-Tech)FOOD AND DRUG ADMINISTRATION (FDA): FOOD AND DRUG ADMINISTRATION (FDA) The FDA oversees the NDA process.It mainly focuses on the disclosure of the ingredients and formulation,assay methods,manufacuring processesand all animal and human testing Amendments were made in 1962 which focused on both saftey and efficacy of new drug products prior to approval and requires investigstor to file Investigational New Drug Application(INDs) prior to testing new drugs in humans. Center of Drug Evaluation And Researh(CDER) under FDA is responsible for drugs and drug efficacy of all prescription and over the counter drug products prior to marketing. CDER is responsible for monitoring drug saftey after initial market approval and has the authority to withdraw from the market posing significant health risk.OVER VIEW OF THE DRUG APPROVAL PROCESS: OVER VIEW OF THE DRUG APPROVAL PROCESS The development process is divided into two section: Preclinical testing: Lead compound selection and animal testing of new chemicals. Clinical testing: Administration of new chemicals to human beingsSlide 4: DRUR DISCOVERY AND LEAD COMPOUND SELECTION BIOLO- GICAL ACTIVITY TESTING FORMULATION DEVELOPMENT SAFTEY TESTING IN ANIMALS IND APPLICATION CLINICAL HOLD IND FILING IND APPROVAL PHASE 1 TRIAL PHASE 2 TRIAL PRASE 3 TRIAL NDA FILING FDA DISAPPROVAL FDA CONDITIONAL APPROVAL FDA APPROVAL MARKET POST APPROVAL SAFTEY REPORTS TO FDA CHEMICAL SYNTHESISDRUG DISCOVERY AND LEAD COMPOUND SLECTION: DRUG DISCOVERY AND LEAD COMPOUND SLECTION A chemical with potential therapeutic benefits is known as a lead compound,must first be identified & researchers usevarious high throughput assay techniques to rapidly screen large numbr of chemicals for biological activity. Random screening as the name implies,requires biological testing of a large variety of diverse compounds from existing chemical libraries. A more mechanism-based drug design is targated synthesis ,on researchers focus on one step in a targeted for drug intervention.While an extensive knowledge of the disease state is requried this more directed approach increases the likelihood of successfully identifying the lead compound. Combination of these discovery techniques is used to identify the lead compounds.PRECLINICAL TESTING: PRECLINICAL TESTING PRECLINICAL TESTING INCLUDE: Discovery testing to ensure biological activity in-vivo Chemical synthesis & scale up to ensure adequate quantities of high purity can be made. Formulation development and stability testing to characterize various chemical properties,develop the initial drug delivery system & determine the stability of the compound. Animal saftey testing to ensure limited toxicities of the lead agent.Slide 7: During discovery testing testing the specific`s of the compounds properties such as, mechanisim of action in animal models,compound specificity,duration of action and SAR are determined. The phisiochemical property of the active compound are determined and the drug delivery system to be used in human testing begins to be developed during this phase. Often times the most appropriate animal model to predict human response is not known.Slide 8: Thus toxicity studies are conducted in at least two animal species, one rodents and another non rodent to obtain a comprehensive view of the potential toxicity. Animal should be given the new drug product by the same route as intended for human. Generally once discovery testing shows therapeutic promise the chemical synthesis, fd, and animal safety testing occurs concurrentlyINVESTIGATION AND NEW DRUG APPLICATIONS: INVESTIGATION AND NEW DRUG APPLICATIONS An investigation new drug application must be filed whanges ith the FDA and approved prior to administering new drug products to humans. IND includes all pre clinical animal data and the name and locations of the investigators who will be performing the planned clinical trials. The clinical trials where IND is not required are lebel changes or a new indication. Major changes in advertisingSlide 10: Change in route of administration, dose, or patient population that significantly increases the risk of the drug. It is not required if the trial is exempt according to the above criteria regardless to whether a placebo is employed as a control group.CLINICAL INVESTIGATIONS: CLINICAL INVESTIGATIONS Clinical investigations involve the administration of a drug to humans.IND must be filed with the FDA and approvd prior to administering new drug products to human beings. This segment of the drug development process requires substantial financial and time commitment. Human testing is divided into 4 phases each with specific objectives: Phase 1 Phase 2 Phase 3 Phase 4PHASE 1 CLINICAL TRIALS: PHASE 1 CLINICAL TRIALS The first series of experiments performed in human beings occur during phase 1 clinical testing.generally 20-30 healthy volunteers are choose. In phase 1 trial the starting dose is generally low,often 1/10 of the highest no effect dose in animal models.after initial treatment is completed additional subjects may be recruited and administersd higher doses to determine the maximum tolerated dose without significant side effect. During this phase the prelimnary ADME data of the parent drug and all metabolites are evaluatedPHASE 2 CLINICAL TRIALS: PHASE 2 CLINICAL TRIALS Phase 2 clinical trial shifts its focus from saftey to efficacy.A large number of people participate (100-300) where majority of the people suffer from targeted illness. Side effect from the new drug is also investigeted Clinical protocols for phase 2 trial must be sent to the FDA as amendments to the IND prior to beginning of the trial.PHASE 3 CLINNICAL TRIALS: PHASE 3 CLINNICAL TRIALS Scientists carefully review of the preclinical and clinical data in evaluating the propossed phase 3 protocol. Specific area of the proposed phase 3 trials are;inclusion/exclusion criteria,dosing regimen,method and timing of data collecyion,duration of treatment & follow up assesment,binding of the drug product and plans to access compliance with the protocol,identification of primary outcome variables,methods to account for dropouts.Slide 15: It is the longest and most comprehensive trials regarding efficacy and saftey of new compounds.significantly larger number of people are choosen (1000-3000patients)who are afflicted with targeted illness are tested. The new drug may be compared to the existing therapeutic regimen or to placebo. The final marketedformulation of the drug product should be optimised prior to the start of these phase 3 clinical trials.PHASE 4 CLINICAL TRIALS: PHASE 4 CLINICAL TRIALS Phase 4 trials are post-approval clinical trials designed for 1 of the several reasons.the NDA may mandate phase 4 testing in a specific patient population to further assess efficacy and side effects. Companies may also choose to conduct additional clinical trials to more fully understand how their product compares to other commercially available therapeutic regimenTHE NEW DRUG APPLICATION: THE NEW DRUG APPLICATION The NDA process is the last hurdle prior to approval and marketing.A NDA document contains a highly detailed informations The primary items of NDA includes: Saftey and efficacy of the drug treatment. Components of drug products. Description of method and controls used in manufacturing the active ingredients and the delivery system and its packing. Proposed labelling. When the NDA is first submitted it is first reviewed for its completenessSlide 18: If the document is sufficiently complete the Nda is accepted for review and assigned a priority status The NDAs for new chemical entities are classified as either ‘P’ priority review or ‘S’ standard review. A ‘P’ rating is given to new drug products with improved therapeutic effects and saftey,and/orside effects in comparision to the currenty marketed drug. The NDAs assigned ‘P’ are expected to be reviewed in a more timely manner than those assigned ‘S’. The decision to accept the NDA is made within 60 days of the date of submission. Once the NDA is approved the FDA has 180 days from the date of submission to complete the review and give the decision of approval or not.POST APPROVAL ACTIVITIES: POST APPROVAL ACTIVITIES SAFTEY MONIT ORING After the NDA has been granted and merketing of the drug product is initiated,the drug saftey is still monitored.sponsers of NDA must submit reports of adverse events periodically For the new drugs these are submitted quaterly for 3 yrs and then annually. Serious adverse events may require minor labeling changes or addition of warning or precaution statement.if serious saftey cocerns arise FDA may withdraw approval.Slide 20: CHANGES TO AN APPROVED PRODUCT Any changes made to an FDA approved dr ug product in cluding component or composition,chemical synthesis,manufacturing process,site,analytical methods,batch size,or labelling must be submitted to the FDA. Depending on the type of change & the impact of change on the quality of drug product notification to the FDA should be made through annual reports or supplemental new drug applications(SNDA).THANK YOU: THANK YOU You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.