Drug development process

FACULTY OF FISHERY SCIENCES
A SEMINAR ON
DRUG DEVELOPMENT MECHANISMS
SUBMITTED BY
SOURAVBHADRA
B.F.Sc 3rd yr. 1st sem
ROLL NO. F/2016/29
SUBMITTED TO:
PROF. Gadadhar dash
H.O.D.
DEPT. OF AAH

INTRODUCTION:
What is Drug?
Any biological,chemical,or synthetic substance which can
produce biological response when it introduced into the
body.
What is Pharmacology?
An experimenital science dealing with the properties of drug
and their effects on living system.
What is Pharmacokinetics & Pharmacodynamics?
What the body does to the drug & What the drug does to the
body.

Stages of DrugDevelopment:
Any drug development process must proceed through
several stages in order to produce a product that is safe,
efficacious, and has passed all regulatory requirements.
Detailed Stages of Drug Development
 Discovery
 Product Characterization
 Formulation, Delivery, Packaging Development
 Pharmacokinetics And Drug Disposition
 Preclinical Toxicology Testing And IND Application
 Bioanalytical Testing
 Clinical Trials

Discovery:
Typically,researchers discover new drugs through:
New insights into a disease process that allow researchers
to design a product to stop or reverse the effects of the
disease.
Many tests of moleculer compounds to find possible
beneficial effects against any of a large number of disease.
Existing treatments that have unanticipated effects.
New technologies,such as those that provide new ways to
target medical products to specific sites within the body or
to manipulate genetic material.

Product Characterization:
When the candidate molecule shows promise as a
therapeutic, it must be characterized—the molecule’s size,
shape, strengths and weaknesses, preferred conditions for
maintaining function, toxicity, bioactivity, and
bioavailability must be determined. Characterization
studies will undergo analytical method development and
validation. Early stage pharmacology studies help to
characterize the underlying mechanism of action of the
compound.

Formulation, Delivery, Packaging Development:
 Drug developers must devise a formulation that ensures
the proper drug delivery parameters.
 Drug formulation and delivery may be refined
continuously until, and even after, the drug’s final
approval.
 Scientists determine the drug’s stability—in the
formulation itself, and for all the parameters involved with
storage and shipment, such as heat, light, and time.
 The formulation must remain potent and sterile; and it
must also remain safe (nontoxic).
 It may also be necessary to perform leachables and
extractables studies on containers or packaging.

Pharmacokinetics And Drug Disposition:
Pharmacokinetic(PK)orADME(Absorption/Distribution/Met
abolism/Excretion) studies provide useful feedback for
formulation scientists.
PK studies yield parameters
such as AUC (area under
the curve represents the total drug
exposure across time), Cmax
(maximum concentration
of the drug in blood), and
Tmax (time at which Cmax is reached). Later on, this data
from animal PK studies is compared to data from early
stage clinical trials to check the predictive power of
animal models.

Preclinical Toxicology Testing and INDApplication:
 Preclinical testing analyzes the bioactivity, safety, and
efficacy of the formulated drug product.
 During the preclinical stage of the development process,
plans for clinical trials and an Investigational New Drug
(IND) application are prepared.
 Studies taking place during the preclinical stage should be
designed to support the clinical studies.

The main stages of preclinical toxicology testing are:
Acute Toxicity Studies:
 Acute toxicity studies look at the effects of one or more
doses administered over a period of up to 24 hours.
 The goal is to determine toxic dose levels and observe
clinical indications of toxicity.
 Usually, at least two mammalian species are tested.
 Data from acute toxicity studies helps to determine doses
for repeated dose studies in animals and Phase I studies in
humans.

Repeated Dose Studies:
 Depending on the duration of the studies, repeated dose
studies may be referred to as subacute, subchronic, or
chronic.
 The specific duration should anticipate the length of the
clinical trial that will be conducted on the new drug.
Again, two species are typically required.

Genetic Toxicity Studies:
 These studies assess the likelihood that the drug
compound is mutagenic or carcinogenic.
 Procedures such as the Ames test (conducted in bacteria)
detect genetic changes.
 DNA damage is assessed in tests using mammalian cells
such as the Mouse Micronucleus Test.
 The Chromosomal Aberration Test and similar procedures
detect damage at the chromosomal level.

Reproductive Toxicity Studies
 Segment I reproductive toxicity studies look at the effects
of the drug on fertility. Segment II and III studies detect
effects on embryonic and post-natal development.
 In general, reproductive toxicity studies must be
completed before a drug can be administered to women of
child-bearing age.

Carcinogenicity Studies:
 . Carcinogenicity studies are usually needed only for
drugs intended for chronic or recurring conditions.
 They are time consuming and expensive, and must be
planned for early in the preclinical testing process

Bioanalytical Testing:
Bioanalytical laboratory work and bioanalytical method
development supports most of the other activities in the
drug development process.
The bioanalytical work is key to proper characterization of
the molecule, assay development, developing optimal
methods for cell culture or fermentation, determining
process yields, and providing quality assurance and
quality control for the entire development process.

Clinical Trials:
 Phase I Clinical Development (Human
Pharmacology):
Typically involves 20-80 healthy volunteers (no women of
childbearing potential).
Emphasis is on drug safety.
Goal is to identify major side effects, metabolism and
routes of excretion.
Lasts about 1 year.
About 70% of drugs will pass this phase.

Phase II Clinical Development (Therapeutic
Exploratory):
Typically involves 100-300 individuals who have the
target disease.
Emphasis is on effectiveness.
Patients receiving the drug are compared to similar
patients receiving a placebo or another drug.
Lasts about 2 years.
About 33% of drugs will pass this phase.

Phase III Clinical Development (Therapeutic
Confirmatory):
Typically involves 1000-3000 patients.
Emphasis is on safety and effectiveness.
Investigates through well-controlled studies different
populations and different dosages as well as uses new
drug in combination with other drugs.
Lasts about 3 years.
25-30% of drugs will pass this phase.

Biologics License Application (BLA) or the New Drug
Application (NDA):
 Pre-NDA period: FDA and drug sponsors meet.
 Submission of NDA: Formal step asking the FDA to
consider approving a drug for marketing.
 FDA has 60 days to decide whether it will file it for
approval consideration.
 If filed, BLAs are currently reviewed by the FDA’s Center
for Biologics Evaluation and Research (CBER). NDAs
are reviewed by the Center for Drug Evaluation and
Research (CDER).

FDA Role:
 The review team evaluates the research on the safety of
the drug and its effectiveness.
 The FDA reviews the information to go on the drug label.
 It inspects the facilities where the drug will be
manufactured.
 The application will be classified as “approvable” or “not
approvable”.
 If approvable, the FDA requests additional information
from the sponsor.
 The NDA is again reviewed.
 Following drug approval, sponsors of the drug will be
required to continually assess the safety of the drug.

Phase 4: Continued comparative studies.
Registration and market introduction:
Post-market surveillance of the drug to continually assess
the safety of the drug.
May include incidence and severity of rare adverse
reactions, cost-effectiveness analyses, comparative trials,
and quality of life studies.

RegulatoryAgency:
Each country has a drug regulatory body which governs
the approval process.
 India- CDSCO (Central Drugs Standards and Control
Organization).
US- FDA (Food and Drug Administration).
UK- MHRA (). Medical and Healthcare Products
Regulatory Agency
European Union- EMEA (European Medicines
Agency)
Drug must be proved to be safe and effective

Conclusion:
 The drug discovery and development process is a long and
complicated process.
 Before any newly discovered drug is placed on the market, it
must undergo extensive testing.
 Each success is built on many, many prior failures.
 Advances in understanding human biology and disease are
opening up exciting new possibilities for breakthrough
medicines.
 At the same time, researchers face great challenges in
understanding and applying these advances to the treatment of
disease. These possibilities will grow as our scientific
knowledge expands and becomes increasingly complex.
 Research-based pharmaceutical companies are committed to
advancing.

References:
 http://www.fda.gov/Drugs/DevelopmentApprovalProc
ess/default.htm
 https://pacificbiolabs.com/stages-of-drug-
development
 https://en.wikipedia.org/wiki/Drug_development
 https://www.google.com/search?q=drug+developmen
t+process+encyclopedia

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