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US Preparation > Drugs > Flashcards

Drugs Flashcards

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1
Q

Public Health Service Act

A

1944

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2
Q

Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)

A

1984

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3
Q

Prescription Drug Marketing Act

A

1987

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4
Q

Prescription Drug User Fee Act PDUFA

A

1992

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5
Q

Federal Advisory Committee Act

A

1972

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6
Q

Food and Drug Administration Modernization Act FDAMA

A

1997

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7
Q

Food and Drug Administration Amendments Act FDAAA

A

2007 Sentinel Initiative

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8
Q

Food and Drug Administration Safety and Innovation Act FDASIA

A

2012 July

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9
Q

21 CFR 310

A

New Drugs

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10
Q

21 CFR 312

A

Investigational New Drug Application IND

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11
Q

21 CFR 314

A

Applications for FDA Approval to Market a New Drug NDA

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12
Q

21 CFR 601

A

Licensing (biological products)

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13
Q

Sentinel Initiative FDAAA

A

track how drugs and other healthcare products

perform once they are approved. May 2008

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14
Q

The Program

A

FDASIA July 2012 PDUFA V reauthorization
NME NDAs and original BLAs, including applications resubmitted after a refuse-to-file (RTF) action, received from 1 October 2012 through 30 September 2017. greater transparency, with two meetings in the review process (i.e., the mid-cycle
meeting and the late-cycle meeting).
priority review designation eight-month action goal, and standard applications have a 12-month action goal.

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15
Q

TPP

A

Target Product Profile - The TPP is a format for a drug development program summary described in terms of labeling concepts, i.e., organized according to the key sections of the drug’s intended labeling. It is prepared by the sponsor, and submission is voluntary.

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16
Q

Drug development tools DDT

A

animal models
biological markers (biomarkers)
clinical outcomes assessments (COA) (e.g., patient reported outcome (PRO) measures)
clinician or caregiver rating scales

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17
Q

Biomarker

A

A characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes or biological responses to a therapeutic intervention. A change to a biomarker following treatment with the drug product can predict or identify safety problems related to the drug or reveal a pharmacological activity expected to predict an eventual benefit from treatment. Biomarkers may reduce uncertainty in drug development and evaluation by providing quantitative predictions about drug performance.

18
Q

patient reported outcome (PRO)

A

A PRO is an instrument that captures drug intervention outcomes during a clinical trial from the patient’s perspective (e.g., change in pain or depression over time from before the therapy began to after it is administered). The PRO uses a questionnaire that is selfadministered by the patient or through interviews by other parties that report on patient perspectives.

19
Q

SEALD

A

CDER’s Study Endpoints and Labeling Development Team (SEALD) can apply the DDT for the qualified use confidently, without the need to reconfirm its utility

20
Q

IND real sense

A

The IND is a claim of exemption from certain FD&C Act labeling requirements, allowing drug shipment in interstate commerce for the purpose of conducting clinical trials

21
Q

Nonclinical/preclinical Testing

A

Prior to submitted an IND
Toxicological and pharmacological data
Evaluate the new drug’s safety before initiating human clinical trials
1 to 4 years. may also conducted in parallel to clinical testing

22
Q

Nonclinical studies are used to

A
  1. assess pharmacodynamic activity and mechanism
    of action
  2. assess drug absorption, distribution to organ systems
    and tissues, and metabolism and excretion pathways
    (ADME)
  3. assess pharmacokinetics
  4. detect overt toxicity, and identify toxic effects and
    principal target organs
  5. assess genotoxic or mutagenic potential
  6. assess carcinogenicity
  7. assess reproductive toxicity and teratogenic potential
  8. assess the safety of drug impurities
  9. estimate dose-response relationships of pharmacological and toxic effects
  10. estimate a safe starting dose for study in humans
  11. suggest clinical safety assessments
23
Q

Subacute toxicity testing

A

Must be conducted in two mammalian species (one nonrodent) and usually involves rats and dogs.
30- to 90-day subacute toxicity studies are required for the full drug development program.
Subacute toxicity testing studies lasting two to four weeks may be sufficient to support Phase 1 and Phase 2 human trials of up to two weeks’ duration

24
Q

Longer-term, repeat-dose toxicity studies

A

required prior to Phase 3 trials and marketing approval
~6 months in rodent species and for chronic administration in a nonrodent species.
ICH - 9 month studies
FDA - 6 months acceptable (chronic conditions with shortterm, intermittent exposure or life-threatening disease)
FDA - 12 months for NCEs where no long-term human
experience is available in the pharmacological class

25
Q

Genotoxicity

A

Prior to initial clinical testing - assessment of mutagenicity in bacteria and chromosomal damage in mammalian cells
Prior to Phase 2 studies - In vivo assessments of genotoxicity

26
Q

Carcinogenicity

A

Not required prior to clinical testing
Maybe postponed to postapproval or not required for some products
rats - 2 years; mice 18 months
knockout mice - 6 months

27
Q

Reproductive Toxicity

A

Fertility and reproduction studies are divided into three
segments:
􀁴􀀁 segment I: fertility and early embryonic development
to implantation
􀁴􀀁 segment II: embryo-fetal development
􀁴􀀁 segment III: prenatal and postnatal development,
including maternal function, in addition to a
requirement for mutagenicity studies

28
Q

21 CFR 312

A

IND

29
Q

IND review team consists of

A

medical officer
pharmacologist/toxicology
chemist
Statistical

30
Q

Phase 1 Clinical study hold reasons

A

unreasonable risk of human subject harm
unqualified investigators
misleading, incomplete or erroneous Investigator’s
Brochure
insufficient information to allow assessment of risk
gender bias in a study of patients with a lifethreatening
disease that affects both genders

31
Q

IND study recruitment advertising is reviewed and approved by

A

IRB

32
Q

Fatal/Life Threatening experience in IND

A

sponsor also must notify FDA
by telephone or fax of any fatal or life threatening
experience associated with the
use of the drug within seven calendar days
of receipt (expedited report). In addition,
the sponsor is required to submit 15-day
follow-up safety reports if new information

33
Q

Annual Reports to the IND

A

Must to submitted within 60 days of the anniversary date of the IND becoming effective

34
Q

IND Inactive

A

If no subjects are entered into clinical studies for a
period of two years, or all investigations are on clinical hold
for one year or more, the IND may be placed on inactive
status, either at the sponsor’s request or at FDA’s initiative.
IND inactive for more than 5 years or unable to resolve deficiencies through a clinical hold. The IND will be terminated.

35
Q

Clinical Trials Data Bank (clinicaltrials.gov)

A

created under Food and Drug Administration Modernization Act (FDAMA) Section 113 to provide the public with current clinical trial information for drugs to treat serious or life-threatening diseases and conditions

36
Q

Treatment IND

A

The drug is intended for a serious or immediately
life-threatening disease.
􀁴􀀁 No comparable or satisfactory alternative drug or
other therapy is available to treat the disease stage
in the intended patient population.
􀁴􀀁 The drug is under investigation in a controlled clinical
trial under an effective IND, or all clinical trials
must have been completed.
􀁴􀀁 The sponsor of the controlled clinical trial is pursuing
marketing approval with due diligence.

37
Q

Early Consultation and Expedited Approval

A

21 CFR 312.82 allows meetings with FDA reviewing officials at the pre-IND stage and again at the End-of-Phase l (EoP1), at the sponsor’s request.
The pre-IND meeting’s purpose is to review and agree on animal study designs needed to initiate human testing, and to discuss Phase 1 trial scope and design and IND content and format.
The EoP1 Meeting is to finalize the design of controlled Phase 2 trials, to ensure data will be sufficient to support marketing approval.

38
Q

Treatment Protocols

A

an IND sponsor or sponsor-investigator may
submit a treatment protocol for an investigational
drug, subject to the criteria in 21 CFR 312.34. In
addition, under 21 CFR 312.83, FDA may ask a
sponsor to submit a treatment protocol for a promising
drug

39
Q

Parallel Track

A

Permits wider access to promising new drugs for AIDS/HIV related diseases. Patients with these
illnesses who have no therapeutic alternatives and
who cannot participate in the controlled clinical
trials can receive investigational drugs that preliminary
studies show to be promising.

40
Q

FDA review of proprietary names

A

safety and promotional aspects. IND phase -180 days; Supplement to NDA/BLA - 90 days
Safety review focuses primarily on preventing medication errors and evaluating other products that may have similar dosage regimens, overlapping strengths, similar names when spoken or a similar appearance when written by hand.
Promotional review is to determine whether the name implies superiority, attempts to minimize risk or overstates efficacy.

41
Q

HIPAA

A

Health Insurance Portability and Accountability Act of 1996; 11- digit code to NDC to allow proper reimbursement billing

42
Q

NDC code

A

12345 - labeler code, set by the FDA (vendor code) involved in the drug’s manufacture, packaging or distribution
123 - product code; entity, strength, dosage form and
formulation
12 - package code; indicates the package forms and sizes

US Preparation (2 decks)

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