The organization which is part of the FDA the chief consumer watchdog in this system - Drug evsluatoon
and reserach or CDERensures brand and Bernice are safe effective and benefits out weights the risks
United States pharmaceutical regulators - Who
FDA
OPDP
DOJ
OIG
R
Regulation concerns - -safety
Quality "
Quantity.
Market flow
R and D incentives Ë
PRICING
PATIENTS
International council for harmonization cad - Standardized medical technology
Medical Affairs - Buffers interest from unswaying medical and scientific communities
Commercial - Sales and marketing arms
RegulatoryAffairs - Liaison between company and regulatory authorities esp the FDA
Pharmacology, toxicology and Clincal research
, Medical Affairs - Active role in generating and disseminating knowledge to HCP, Clincal experts and
leading research
1. Clinical information development and execution of Clincal trials
Work with clinical experts and scientists to share latest knowledge and advances in medical research
Education Materials
FIne Graine
Keep current on scholarships
HEOR (greater restrictions on health care (efficacy, safety, quality,
Roles and Responsible of MEdical Affairs - Medical information services: Answering Questions
Pharmacovigilence: Documenting and answering questions from external consumers
Medical science liaisons: communicate directly with healthcare providers regarding merits of the
companies products
Drug Discovery and Development - Lead discovery-screening natural compounds collections
Screening corporate compound collections
In silico screening (auto dock)
Rational drug drug design
Based on knowledge of biological target
Combinatory chemistry
Quickly/effectively synthesize large numbers of potential small molecule drug candidates
A rule of 5 - .
Less than 5 hydrogen b ond donors (which can be estimated by counting the total number of OH and NH
groups in the molecule.)
Less than 5 hydrogen-bond acceptors (estimated by the total of N and O atoms in the molecule.)
Molecular weight of less than 500 Daltons
A partitioning coefficient of less than 5
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