40:
354:
1094:
381:
are filed to make a drug available for the treatment of serious or immediately life-threatening conditions prior to FDA approval. Serious diseases or conditions are stroke, schizophrenia, rheumatoid arthritis, osteoarthritis, chronic depression, seizures, Alzheimer's dementia, amyotrophic lateral
388:
are filed for multiple, closely related compounds in order to screen for the preferred compounds or formulations. The preferred compound can then be developed under a separate IND. Used for screening different salts, esters and other drug derivatives that are chemically different, but
417:
on the qualifications of clinical investigators, that is, the professionals (generally physicians) who oversee the administration of the experimental drug to the study subjects. Used to assess whether the investigators are qualified to fulfill their clinical trial
342:
223:
299:
411:
includes composition, manufacturer, and stability of, and the controls used for, manufacturing the drug. Used to ensure that the company can adequately produce and supply consistent batches of the drug.
371:, also called compassionate use or single-patient INDs, are filed for emergency use of an unapproved drug when the clinical situation does not allow sufficient time to submit an IND in accordance with
405:
consists of animal pharmacology and toxicology studies to assess whether the drug is safe for testing in humans. Also included are any previous experience with the drug in humans (often foreign use).
743:
445:
intended to educate the trial investigators of the significant facts about the trial drug they need to know to conduct their clinical trial with the least hazard to the subjects or patients.
292:
452:
may begin. If the FDA detects a problem, it may place a clinical hold on the IND, prohibiting the start of the clinical studies until the problem is resolved, as outlined in
285:
424:
are the centerpiece of the IND. Detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose the subjects to unnecessary risks.
238:
70:
544:
271:
85:
115:
365:
are non-commercial INDs filed by researchers to study an unapproved drug or to study an approved drug for a new indication or in a new patient population.
508:). It stopped accepting new patients in 1992 after public health authorities concluded there was no scientific value to it, and due to President
505:
466:
454:
334:
266:
1077:
834:
17:
372:
332:(usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at
1128:
532:
65:
341:. Similar procedures are followed in the European Union, Japan, and Canada due to regulatory harmonization efforts by the
448:
Once an IND application is submitted, the FDA has 30 days to object to the IND or it automatically becomes effective and
243:
125:
685:
774:
604:
564:
716:
646:
699:
Troetel, W.M.: Achieving a
Successful US IND Filing (2) The Regulatory Affairs Journal. 6: 104–108, February 1995.
1052:
721:
464:
An IND must be labeled "Caution: New Drug – Limited by
Federal (or United States) law to investigational use," per
195:
1072:
696:
Troetel, W.M.: Achieving a
Successful US IND Filing (1) The Regulatory Affairs Journal. 6: 22–28, January 1995.
130:
80:
375:, 312.24. These are most commonly used for life-threatening conditions for which there is no standard treatment.
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747:
313:
261:
120:
512:
administration's desire to "get tough on crime and drugs." As of 2011, four patients continue to receive
1047:
662:
569:
185:
178:
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233:
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1024:
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325:
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90:
999:
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51:
1123:
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1004:
898:
807:
481:
163:
8:
1014:
946:
929:
908:
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802:
574:
485:
329:
692:
ICH Guidance for
Industry, E6 Good Clinical Practice: Consolidated Guidance. BROKEN LINK
1009:
972:
941:
711:
457:
492:. About half of the INDs fail in preclinical and clinical phases of drug development.
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903:
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509:
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47:
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994:
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obtains permission to start human clinical trials and to ship an experimental drug
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625:
John S. McInnes (2011). "New Drug
Applications". In Shayne C. Gad (ed.).
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876:
814:
688:
Center for Drug
Evaluation and Research, Food and Drug Administration.
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from the research subjects, to obtain a review of the study by an
398:
The IND application may be divided into the following categories:
435:(IRB), and to adhere to the investigational new drug regulations.
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752:
545:
Abigail
Alliance for Better Access to Developmental Drugs
531:
classified as an investigational new drug (IND) in its
605:"E8(R1) General Considerations for Clinical Studies"
33:
Regulation of therapeutic goods in the United States
686:Investigational New Drug (IND) Application Process
1110:
624:
506:Compassionate Investigational New Drug program
768:
293:
427:Other commitments are commitments to obtain
663:"4 Americans get medical pot from the feds"
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761:
480:Approximately two-thirds of both INDs and
300:
286:
38:
702:
835:Separation of prescribing and dispensing
439:An IND application must also include an
352:
516:from the government under the program.
343:International Council for Harmonisation
116:Department of Health and Human Services
14:
1111:
756:
631:Pharmaceutical Sciences Encyclopedia
533:Anthrax Vaccine Immunization Program
66:Federal Food, Drug, and Cosmetic Act
244:Single Convention on Narcotic Drugs
24:
565:FDA Fast Track Development Program
324:) program is the means by which a
25:
1140:
717:Concise Encyclopedia of Economics
679:
1093:
1092:
1053:List of pharmaceutical companies
722:Library of Economics and Liberty
382:sclerosis (ALS), and narcolepsy.
196:Abbreviated New Drug Application
1073:Pharmacies in the United States
81:Prescription Drug Marketing Act
618:
597:
393:
256:Non-governmental organizations
13:
1:
590:
555:Biologics license application
475:
363:Research or investigator INDs
1129:Food and Drug Administration
782:
748:Food and Drug Administration
639:10.1002/9780470571224.pse420
389:pharmacodynamically similar.
357:Timeline for drug evaluation
314:Food and Drug Administration
262:National Academy of Medicine
121:Food and Drug Administration
27:USFDA program and prodecures
7:
1048:Pharmacy benefit management
570:Good Manufacturing Practice
538:
495:
186:Randomized controlled trial
10:
1145:
744:IND Forms and Instructions
433:institutional review board
218:International coordination
1088:
1023:
960:
917:
843:
790:
409:Manufacturing Information
229:Uppsala Monitoring Centre
98:Marihuana Tax Act of 1937
76:Controlled Substances Act
1043:Investigational New Drug
884:Pharmaceutical chemistry
830:Pharmacological activity
525:US Department of Defense
422:Clinical trial protocols
415:Investigator information
348:
318:Investigational New Drug
169:Investigational New Drug
18:Investigational new drug
1025:Pharmaceutical industry
844:Pharmaceutical sciences
442:Investigator's Brochure
358:
326:pharmaceutical company
52:Over-the-counter drugs
1000:Pharmacist prescriber
985:Consultant pharmacist
671:. September 28, 2011.
627:New Drug Applications
521:Executive Order 13139
482:new drug applications
356:
126:Department of Justice
1068:Pharmacies of Norway
1005:Pharmacy informatics
899:Pharmacoepidemiology
808:Prehistoric medicine
486:small-molecule drugs
164:New Drug Application
1015:Veterinary pharmacy
947:Pharmacy technician
909:Pharmacocybernetics
803:History of pharmacy
612:Efficacy Guidelines
575:Inverse benefit law
403:Preclinical testing
201:Fast track approval
110:Government agencies
1010:Specialty pharmacy
973:Community pharmacy
942:Pharmacy residency
712:David R. Henderson
490:biopharmaceuticals
369:Emergency Use INDs
359:
330:across state lines
312:The United States
48:Prescription drugs
1119:Clinical research
1106:
1105:
1063:Pharmacy in China
990:Hospital pharmacy
968:Clinical pharmacy
904:Pharmacovigilance
820:Prescription drug
704:Henninger, Daniel
510:George H. W. Bush
504:IND program (the
502:medical marijuana
310:
309:
191:Pharmacovigilance
16:(Redirected from
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1096:
1095:
1058:Medication costs
1033:Drug development
995:Nuclear pharmacy
872:Pharmacogenomics
860:Pharmacodynamics
856:Pharmacokinetics
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720:(1st ed.).
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429:informed consent
373:21 CFR §§ 312.23
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159:Drug development
86:Hatch-Waxman Act
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680:External links
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488:. The rest is
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386:Screening INDs
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1124:Drug safety
918:Professions
798:Compounding
580:Orphan drug
550:Animal drug
484:(NDAs) are
467:21 CFR
455:21 CFR
394:Application
335:21 CFR
154:Drug design
1113:Categories
925:Pharmacist
877:Toxicology
815:Medication
708:"Drug Lag"
591:References
476:Prevalence
91:exemptions
739:163149563
731:317650570
1098:Category
825:Pharmacy
784:Pharmacy
735:50016270
706:(2002).
668:CBS News
539:See also
535:(AVIP).
514:cannabis
496:Examples
1078:History
791:General
714:(ed.).
418:duties.
143:Process
858:&
729:
645:
614:. ICH.
585:TOL101
523:, the
458:312.42
179:phases
71:CDAPCA
710:. In
608:(PDF)
470:312.6
349:Types
272:NORML
267:RADAR
239:CIOMS
978:shop
930:List
727:OCLC
643:ISBN
635:doi
338:312
322:IND
316:'s
234:WHO
224:ICH
131:DEA
60:Law
1115::
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