Term
| HOW CAN NEW DRUGS BE MADE? |
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Definition
| BY de novo (FROM THE BEGINNING), EXTRACTED FROM NATURE, OR A COMBINATION OF THOSE PROCESSES. |
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Term
| ARE SYNTHETIC DRUGS FROM NATURE? |
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Definition
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Term
| SOME DRUGS MAY BE BASED OFF OF AN _____ COMPOUND AND MANIPULATED TO SERVE DIFFERENT PURPOSES. |
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Definition
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Term
| CAN DRUG INDICATIONS OR ACTIVITY BE FOUND ACCIDENTALLY? |
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Definition
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Term
| HOW MANY PARTS ARE THERE FOR THE PROCESS OF DRUG DEVELOPMENT? |
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Definition
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Term
| HOW MANY CLINICAL TRIALS ARE THERE IN PLASE III? |
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Definition
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Term
| WHAT HAPPENS IN THE 1ST PROCESS? |
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Definition
| PRECLINICAL TRIALS. THERE IS CELLULAR AND ANIMAL TESTING. |
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Term
| WHAT ARE SOME QUESTIONS THAT NEED TO BE ANSWERED IN THE PRECLINICAL TRIALS? |
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Definition
DOES THE DRUG HAVE HARMFUL OR BENEFICIAL EFFECTS ON VITAL ORGANS? WHAT IS THE MECHANISM OF ACTION OF THE DRUG? DOES THE DRUG HAVE A THERAPEUTIC EFFECT ON THE DESIRED ORGAN/SYSTEM? WHAT ARE THE PHARMACOKINETIC PROPERTIES OF THE DRUG?
ASSESS TOXICITY (ACUTE AND CHRONIC), TERATOGENIC, MUTAGENIC, AND CARCINOGENIC PROPERTIES. |
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Term
| WHAT HAPPENS DURING THE 2ND PROCESS OF DRUG DEVELOPMENT? |
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Definition
| APPLICATION TO FDA- INVESTIGATIONAL NEW DRUG (IND) APPLICATION |
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Term
| DURING PROCESS 2 WHAT MUST HAPPEN BEFORE ANY STUDIES IN HUMANS CAN OCCUR? |
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Definition
| FOOD AND DRUG ADMINISTRATION HAS TO APPROVE THE APPLICATION FOR THE NEW DRUG. |
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Term
| WHAT MUST THE APPLICATION CONSIST OF THAT IS SUBMITTED IN PROCESS 2 TO THE FDA? |
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Definition
| DRUG DESCRIPTION, RESULTS IN PRECLINICAL STUDIES, DESIGN AND METHODS AND QUALIFICATIONS OF INVESTIGATORS. |
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Term
| WHAT HAPPENS IN PHASE 1 OF CLINICAL TRIALS? |
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Definition
| HEALTHY HUMANS ARE USED TO FIND THE PHARMACOKINETIC PROPERTIES AND DETERMINE SAFETY. THE HUMANS ARE TYPICALLY SMALL GROUPS AND THERE ARE A VARY OF DRUG DOSAGES. |
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Term
| WHAT HAPPENS IN PHASE 2 OF CLINICAL TRIALS? |
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Definition
| HUMANS THAT HAVE THE DISEASE THAT THE IND IS PROPOSED TO TREAT ARE GIVEN THE DRUG. THESE GROUPS ARE SMALL AND THE CLINICAL TRIALS ASSESSES EFFICACY AND SAFETY OF THE DRUG. |
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Term
| WHAT HAPPENS IN PHASE 3 OF CLINICAL TRIALS. |
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Definition
| COMPARISOIN IS MADE OF THE IND WITH OTHER DRUGS OR TREATMENT PLANS. LARGE GROUPS ARE MULTIPLE TRIAL SETS ARE USED FOR THIS. |
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Term
| WHAT HAPPENS IN THE 4TH PROCESS OF DRUG DEVELOPMENT? |
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Definition
| NEW DRUG APPLICATION. THE MANUFACTURER REQUEST FDA APPRIVAL TO MARKET THE NEW DRUG. THE DRUG MUST BE LABELED FOR SPECIFIC INDICATIONS. |
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Term
| WHAT HAPPENS IN THE 5TH PROCESS OF DRUG DEVELOPMENT? |
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Definition
| POSTMARKETING PHASE. AKA PHASE 4. THE FDA MONITORS DRUG SAFETY IN GENERAL PUBLIC. VOLUNTARY REPORTING OF ADVERSE DRUG EFFECTS VIA MEDWATCH. |
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Term
| WHAT DOES THE FEDERAL DRUG REGULATION DEAL WITH? |
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Definition
| DEAL WITH EITHER DRUG SAFETY AND EFFICACY (LABELING, DRUG COMPOSITION, ETC..) OR WITH THE PREVENTION OF DRUG ABUSE. |
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Term
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Definition
| THOSE DRUGS THAT CAN BE USED TO TREAT RARE DISEASES (SMALL TARGET POPULATION MEAN LITTLE REVENUE, SO GOVERNMENT GIVES A TAX BREAK TO THESE MANUFACTURERS) |
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Term
| HOW CAN DRUGS RECEIVED ACCELERATED DRUG APPRIVAL? |
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Definition
| IF THEY TREAT LIFE-THREATENING ILLNESSES (AIDS OR CANCER), AND CAN BE USED EXPERIMENTALLY. |
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Term
| WHAT HAPPENED AS A RESULT OF THE HARRISON NARCOTICS ACT OF 1914? |
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Definition
| IT PROHIBITED PHYSICANS FROM GIVING DRUG-DEPENDED PATIENTS OPIOIDS. |
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Term
| WHAT IS A CONTROLLED SUBSTANCE ACT? |
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Definition
| IT CATEGORIZES DRUGS BASES ON THEIR ABUSE POTENTIAL. IT CONSISTS OF 5 CLASSES. |
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Term
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Definition
| HIGH ABUSE POTENTIAL AND NO MEDICAL USE. EX. LCD OR HEROIN |
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Term
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Definition
| HIGH ABUSE POTENTIAL BUT MAY HAVE MEDICAL USE. EX. MORPHINE, METHADONE |
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Term
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Definition
| MODERATE ABUSE POTENTIAL, PENALTIES FOR ILLEGAL POSSESSION. EX. KETAMINE |
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Term
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Definition
| LOW ABUSE POTENTIAL. EX VALIUM |
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Term
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Definition
| LOWEST ABUSE POTENTIAL, MAY NOT NEED A PRESCIPTION. EX LOMOTIL |
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Term
| HOW MANY YEARS DOES THE PATENT OF A NEW DRUG EXPIRE AFTER FILING OF APPLICATION? WHAT HAPPENS AFTER THAT? |
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Definition
| 20 YEARS. GENERICS BECOMES AVAILABLE. |
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Term
| HOW MANY YEARS DOES IT TYPICALLY TAKE UNTIL CLINICAL TRIALS START? |
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Definition
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Term
| HOW MANY YEARS UNTIL THE NEW DRUG APPLICATION CAN START? |
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Definition
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