DRUG schedules

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 2: --The sponsor analyzes clinical data. If there is enough evidence based on safety and effectiveness to meet FDA specifications for market approval, then the sponsor submits an NDA (NEW DRUG APPROVAL) application to the FDA

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 2: --The sponsor analyzes clinical data. If there is enough evidence based on __________ and ____________ to meet FDA specifications for market approval, then the sponsor submits an NDA (__________ _____________ APPROVAL) application to the FDA

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 3: --If the NDA is approved by the FDA, then the sponsor may market. --Once on the market adverse reactions to the medication are reported to the FDA. Anyone can report an adverse reaction to the FDA but sponsors are by law required to do so. Sponsors maintain departments called Pharmacovigilence to handle, research and report adverse events to the FDA. These departments are staffed by MDs, PHDs, Pharm D and nurses with advance science degrees

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 3: --If the NDA is approved by the FDA, then the sponsor may _________. --Once on the market adverse reactions to the medication are reported to the FDA. _____________ can report an adverse reaction to the FDA but ______________ are by law required to do so. Sponsors maintain departments called ___________________ to handle, ____________ and report adverse events to the FDA. These departments are staffed by MDs, PHDs, Pharm D and nurses with advance science degrees

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 3: --Fast tracking= Orphan drugs; rare (Brand new drugs) --Post market surveillance: specifically for the drug market. --Pharmacovigilence

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 3: --___________ tracking= Orphan drugs; rare (Brand new drugs) --Post market surveillance: specifically for the drug market. --Pharmacovigilence

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET --Summary: 1. The pharmaceutical company sponsor submits 2.NDA--NEW DRUG APPROVAL 3. FDA 4. MARKET

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET --Summary: 1. ________ ______________ ______________ _____________ 2.NDA--______ _________ APPROVAL 3. FDA 4. MARKET

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: --1. The sponsor is responsible to testing and submitting to the FDA evidence that the drug is safe and effective (S+E). Evidence is based on lab studies including animal studies conducted by the sponsor following FDA regulations/ guidances.

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: --1. The _________ is responsible to testing and submitting to the FDA evidence that the drug is _______ and _________ (______). Evidence is based on lab studies including animal studies conducted by the sponsor following FDA regulations/ guidances.

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: --Clinical trials are divided into 1. Clinical 1 trials--under 100 healthy persons, testing safety only 2. Clinical II trials--several hundred sick persons, testing safety and efficacy. 3. Clinical III trials several 1000 sick persons, testing safety and efficacy. --These trials from beginning to end are monitored by and IRB (Internal Review Board). The FDA defines what constitutes a legal IRB. IF the FDA finds any problems in the process, it can order a "clinical hold" to delay investigation. --I.E. 5-6000 people; Clinical trials IV, would primarily become several subgroups.

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: --Clinical trials are divided into 1. Clinical 1 trials--_________ __________ healthy persons, testing ________ only 2. Clinical II trials--several _________ sick persons, testing ________ and ___________. 3. Clinical III trials several _________ sick persons, testing ___________ and ___________. --These trials from beginning to end are monitored by and IRB (__________ ___________ Board). The FDA defines what constitutes a legal IRB. IF the FDA finds any problems in the process, it can order a "_________ hold" to delay investigation. --I.E. 5-6000 people; Clinical trials IV, would primarily become several _____________.

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: 2. The sponsor requests and IND (INVESTIGATIVE NEW DRUG) application from CDER (CENTER FOR DRUG EVALUATION AND RESEARCH). cder explains what information is needed in the application and the particular FDA regulations to follow.

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: 2. The ______ requests and IND (_________ __________ DRUG) application from CDER (_________ FOR __________ EVALUATION AND RESEARCH). cder explains what information is needed in the application and the particular FDA regulations to follow.

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: 3. The sponsor submits the IND to the FDA. 30 days later the sponsor receives approval/ non-approval from the FDA. If approved, the sponsor can now move to clinical trials (humans).

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: 3. The ___________ submits the IND to the FDA. 30 days later the sponsor receives __________/ _________ approval from the FDA. If ___________, the sponsor can now move to clinical trials (____________).

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: 4. Clinical trials on humans must follow very strict guidelines established by the FDA. This is to assure that the trials follow good science, but also and more importantly, that human subjects are protected.

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 1: 4. Clinical trials on humans must follow very strict guidelines established by the FDA. This is to assure that the trials follow good science, but also and more importantly, that human subjects are ________.

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 2: --The FDA committee reviewing the NDA consist of: --Physicians --Statisticians --Chemists --Pharmacologists and other scientists

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 2: --The FDA committee reviewing the NDA consist of: --____________ --______________ --_____________ --Pharmacologists and other scientists

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 2: --The NDA includes full information of manufacturing specifications, bioavailability data, method of analysis of each dosage from the sponsor intends to market, packaging, labeling for both physician and customer. --If ingredients are patented than links to the patent

DRUG DEVELOPMENT AND FDA APPROVAL TO MARKET DETAIL 2: --The NDA includes full ___________ of manufacturing specifications, bioavailability data, ___________ of analysis of each dosage from the sponsor intends to market, packaging, labeling for both physician and customer. --If ingredients are patented than links to the patent

DRUG SCHEDULES: --Drugs, substances and certain chemicals used to make drugs are classified into five distinct categories or schedules depending upon the drug's acceptable medical use and the drug's abuse or dependency potential. The abuse rate is a determinate factor in the scheduling of the drug; for example, schedule I drugs have a high potential for abuse and the potential to create severe psychological and or physical dependence. As the drug schedule changes from 2-3 to does the abuse potential for schedule 5 drugs, which represents the least potential for abuse.

DRUG SCHEDULES: --Drugs, substances and certain chemicals used to make drugs are classified into five distinct categories or schedules depending upon the drug's acceptable medical use and the drug's abuse or dependency potential. The ____ rate is a determinate factor in the scheduling of the drug; for example, schedule_____ drugs have a _______ potential for ________ and the potential to create severe ___________ and or __________ dependence. As the drug schedule changes from 2-3 so does the abuse potential for schedule ____ drugs, which represents the least potential for abuse.

DRUGS SCHEDULES: --A listing of drugs and their schedule are located at the controlled substance act (CSA) scheduling or CSA scheduling by alphabetical order. These lists describes the basic or parents chemical and do not necessarily describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may also be classified as controlled substances.

DRUGS SCHEDULES: --A listing of drugs and their schedule are located at the controlled substance act (CSA) scheduling or CSA scheduling by alphabetical order. These lists describes the basic or parents chemical and do not necessarily describe the salts, isomers and salts of isomers, esters, ethers and derivatives which may also be classified as controlled substances.

DRUGS SCHEDULES: --Please note that a substance need not be listed as a controlled substance to be treated as a schedule I substance for criminal prosecution. A controlled substance analogue is a substance which is intended for human consumption and is structurally or pharmacologically substantially similar to or is represented as being similar to a schedule I or II, substance is not an approved medication in the U.S.

DRUGS SCHEDULES: --Please note that a substance need not be listed as a controlled substance to be treated as a schedule I substance for criminal prosecution. A controlled substance analogue is a substance which is intended for human consumption and is structurally or pharmacologically substantially similar to or is represented as being similar to a schedule I or II, substance is not an approved medication in the U.S.

Schedule I --Schedule I drugs, substances or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse. Some examples of schedule I drugs are: --Heroin, lysergic acid diethylamide (LSD), marijuna (Cannabis), ecstasy, and meth.

Schedule I --Schedule ____ drugs, substances or chemicals are defined as drugs with no currently accepted medical use and a ________ potential for _______. Some examples of schedule I drugs are: --________, lysergic acid diethylamide (LSD), __________ (Cannabis), ecstasy, and _________.

Schedule II: --Schedule II drugs, substances or chemicals are defined as drugs with a high potential for abuse, with use potentially leading to severe psychological or physical dependence. These drugs are also considered dangerous. Some examples of schedule II drugs are: --Combination products with less than 15 milligrams of hydrocodone per dosage unit (Vicodin), cocaine, methamphetamine, methadone, oxycodone, adderall.

Schedule II: --Schedule II drugs, substances or chemicals are defined as drugs with a ________ potential for ________, with use potentially leading to severe ________ or physical __________. These drugs are also considered ____________. Some examples of schedule II drugs are: --Combination products with less than 15 milligrams of _________- per dosage unit (Vicodin), __________, methamphetamine, methadone, _________, adderall.

Schedule III: --Schedule III drugs, substances or chemicals are defined as drugs with a moderate to low potential for physical and psychological dependence. Schedule III drugs abuse potential is less than schedule I and schedule II drugs but more than schedule IV. --Some examples of schedule III drugs are: Products containing less than 90 milligrams of codeine per dosage unit (Tylenol with codeine) ketamine, anabolic steroids, testosterone.

Schedule III: --Schedule III drugs, substances or chemicals are defined as drugs with a __________ to ________ potential for physical and psychological dependence. Schedule III drugs abuse potential is ________ than schedule I and schedule II drugs but more than schedule IV. --Some examples of schedule III drugs are: Products containing less than 90 milligrams of ________ per dosage unit (Tylenol with codeine) ketamine, anabolic steroids, testosterone.

Schedule IV: --Schedule IV drugs, substances or chemicals are defined as drugs with a low potential for abuse and low risk of dependence. Some examples are xanax, soma, ativan, valium, tramadol

Schedule IV: --Schedule IV drugs, substances or chemicals are defined as drugs with a _______ potential for ______ and low risk of dependence. Some examples are ________, _______, ativan, valium, tramadol

Schedule V drugs: --Substances or chemicals are defined as drugs with lower potential for abuse than schedule IV and consist of preparations containing limited quantities of certain narcotics. Schedule V drugs are generally used for antidiarrheal, antitussive and analgesic purposes.

Schedule V drugs: --Substances or chemicals are defined as drugs with lower potential for abuse than schedule IV and consist of preparations containing _______ quantities of certain narcotics. Schedule V drugs are generally used for __________, antitussive and analgesic purposes.