Pharmaceutical Regulations

Question 1

What is the ICH?

Answer 1

International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Scientific/technical aspects of drug registration

Question 2

What is GCP?

Answer 2

Good Clinical Practices - Standards for ensuring accurate clinical trial data and confidentiality of patients

Question 3

Sponsor?

Answer 3

Pharma company paying for the clinical trial

Question 4

What is an IRB?

Answer 4

Institutional Review Board - FDA regulated group that reviews biomedical research

Question 5

What is ALCOA?

Answer 5

Data integrity - attributable, legible, contemporaneous, original, accurate

Question 6

Pharmacological?

Answer 6

The uses, effects, and modes of action of drugs.

Question 7

Pharmacodynamics?

Answer 7

The branch of pharmacology concerned with the effects of drugs and the mechanism of their action.

Question 8

Concomitant drugs?

Answer 8

Two or more drugs used or given at or almost at the same time.

Question 9

Clinical Trial - Phase 1

Answer 9

Test new drug - 1) safety and dosage range, 2) 20-80 patients , 3) identify side effects, 4) how body absorb drug 5) $4M avg cost, 4) several months duration, 6) 70% of drugs move to next phase

Question 10

Clinical Trial - Phase 2

Answer 10

1) Drug efficacy and side effects, 2) 100 - 300 patients, 3) $13M avg cost, 4) 2 years duration, 5) 33% of drugs move to next phase

Question 11

Clinical Trial - Phase 3

Answer 11

1) compared to standard equivalent drugs, 2) 1-3K patients, 3) submit for FDA approval, 4) $11-53M cost, 5) $20M avg cost, 6) 1-4 years, 7) 25% move to next phase

Question 12

Clinical Trial - Phase 4

Answer 12

1) Post marketing safety surveillance - track drug’s affect on various populations and any side-effects from long-term use, 2) identify other indications, 3) 3K+ patients, 4) $22M avg cost, 5) duration -

Question 13

Pharmacovigilance (PV / PhV)

Answer 13

Also known as drug safety - monitoring and prevention of adverse effects

Question 14

IND

Answer 14

Investigational New Drug

Question 15

Declaration of Helsinki

Answer 15

Finland - 1964 - set of ethical principles for medical research involving human subjects (protect people!)

Question 16

ICH E3

Answer 16

Structure of clinical study reports

Question 17

ICH E6

Answer 17

Ethical and scientific standards for clinical trials. 1) ethical/GCP, 2) cost/benefit, 3) patient safety, 4) adequate information, 5) clear protocol - scientifically sound, 6) IRB - safeguards, 7) only physicians can make medical decision for patients, 8) qualified professionals, 9) informed consent from all patients (risks), 10) data management, 11) confidentiality, 12) GMP, 13) quality systems

Question 18

ICH E7

Answer 18

Clinical trial guidelines for geriatric populations

Question 19

ICH E10

Answer 19

Clinical trial guidelines for control groups

Question 20

IRB / IEC

Answer 20

Institutional Review Board - Independent Ethics Committee - reviews methods proposed for research to ensure that they are ethical

Question 21

Informed Consent

Answer 21

Permission granted by a patient based on a full knowledge of the possible risks and benefits.

Question 22

GMP

Answer 22

Good Manufacturing Practices

Question 23

CRO

Answer 23

Contract Research Organization - organization contracted by the Sponsor to perform one or more trial-related duties.

Question 24

Chief Investigator

Answer 24

Leads and manages the clinical trial

Question 25

Sponsor

Answer 25

Owns and finances the clinical trial - manages risk

Question 26

GDPR

Answer 26

General Data Protection Regulation - EU law on data protection and privacy - addresses transfer of personal data outside the EU and EEA areas

Question 27

21 CFR

Answer 27

Code of Federal Regulations Title 21 - digital signatures, electronic records, marketing,