Scribd
Upload
238 views5 pages

Drug Development Process - Part 1

The document summarizes key steps in the drug development process including target identification, pre-clinical research, and pharmacokinetic testing. Target identification involves discovering disease targets and compounds like hits and leads that show desired therapeutic effects. Pre-clinical research evaluates drug safety and efficacy through in vitro and in vivo studies before human testing. Pharmacokinetic studies assess drug absorption, distribution, metabolism and excretion, first through rapid in vivo screening methods then more comprehensive pharmacokinetic analysis if results are promising.

Uploaded by

Nguyễn Thế Thao
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
238 views5 pages

Drug Development Process - Part 1

The document summarizes key steps in the drug development process including target identification, pre-clinical research, and pharmacokinetic testing. Target identification involves discovering disease targets and compounds like hits and leads that show desired therapeutic effects. Pre-clinical research evaluates drug safety and efficacy through in vitro and in vivo studies before human testing. Pharmacokinetic studies assess drug absorption, distribution, metabolism and excretion, first through rapid in vivo screening methods then more comprehensive pharmacokinetic analysis if results are promising.

Uploaded by

Nguyễn Thế Thao
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 5

DRUG DEVELOPMENT PROCESS – Objectives

Part 1
1. Drug invention and development
timeline
2. Pharmaceutical and biotechnology
landscape
3. Compound selection and preclinical
trials

29 Jun 2020

Overview of drug development Overview of drug development


process process - timeline
Overview of drug development Overview of drug development
process - Cost process - Cost

Target identification Target identification


Target identification Target identification
• Target discovery, which involves the identification and early
validation of disease-modifying targets, is an essential first
step in the drug discovery pipeline.
• A hit compound is a molecule that shows the desired type
of activity in a screening assay
• Hit to lead (H2L) stage of drug discovery which aims to
discover compounds of interest (leads) from a selection of
compounds (hits) that demonstrate promising therapeutic
effects.
• The hit to lead process, which is also referred to as lead
generation, typically occurs following the completion of
target validation, assay development, and high-throughput
screening studies
• A lead compound has pharmacological or biological activity
likely to be therapeutically useful

Target identification Target identification


• Phenotypic screening is a type of screening used in
biological research and drug discovery to identify substances
such as small molecules, peptides, or RNAi that alter
the phenotype of a cell or an organism in a desired manner.
• Target validation is the first step in discovering a new drug
and can typically take 2-6 months. The process involves the
application of a range of techniques that aim to
demonstrate that drug effects on the target can provide a
therapeutic benefit with an acceptable safety window
• Lead optimization aims at enhancing the most promising
compounds to improve effectiveness, diminish toxicity, or
increase absorption. Many of the technologies for lead
discovery overlap with lead optimization as researchers
attempt to incorporate the best drug characteristics early in
the process
Pre-clinical research Pre-clinical research
• The two types of preclinical research are: in vitro and in • FDA requires researchers to use good laboratory practices
vivo (GLP), defined in medical product development regulations,
• Usually, preclinical studies are not very large. However, for preclinical laboratory studies.
these studies must provide detailed information on • Good laboratory practices (GLP), set the minimum basic
dosing and toxicity levels. After preclinical testing, requirements for:
researchers review their findings and decide whether – study conduct
the drug should be tested in people. – personnel
– facilities
– evaluate the efficacy of new drug products quickly and
accurately – equipment
– provide critical information for clinical trials – written protocols
– operating procedures
– help ensure patient safety
– study reports
– meet FDA and international requirements for new drug – and a system of quality assurance oversight for each study to
submissions help assure the safety of FDA-regulated product

In Vitro PK and In Vivo PK


Animal use in preclinical research
3R principles

Russell WMS, 1959, The principles of humane experiment technique, London Methuen, pp. 17-23 15
In Vitro PK and In Vivo PK In Vivo PK - RACE

• RACE: This experiment is a rapid and efficient


compressed in vivo PK screening method to determine
the pharmacokinetic attributes of novel chemical
probes. A small cohort of animals (4 mice or 2
rats/experiment). R.A.C.E. is also to evaluate varying
formulation excipients for improving solubility and
absorption
• Comprehensive PK: compounds that show promising
PK profiles or that are further developed, can be
subjected to a comprehensive pharmacokinetic
analysis and metabolite identification study

In Vivo PK – Comprehensive PK

You might also like