Md. Saydur Rahman presented on the application of biopharmaceutics in new drug development. Biopharmaceutics studies the chemical and physical properties of drugs and their biological effects. Developing new drugs is a long, expensive process involving discovery, pre-clinical testing, clinical trials, and post-approval surveillance. Biopharmaceutics is important throughout this process to understand a drug's absorption, distribution, metabolism, and excretion. Early stages involve finding lead compounds through target identification and validation. Pre-clinical testing assesses toxicity, kinetics, and carcinogenicity in vitro and in vivo before human trials. Clinical trials have three phases to evaluate safety, efficacy, and side effects. Post-marketing surveillance monitors drugs after approval.

1. WELLCOME TO
MY
PRESENTATION
MD. Saydur Rahman
ID:05170101350
sec: 6A
Department of Pharmacy,
Northern University Bangladesh

2. TOPICS NAME :Applicaton of biopharmaceutics in
new drug development.

3. contents
 Introduction
 Importance of bio pharmaceutics in development process
 Discovery
 Pre-clinical testing
 Clinical trials
 Post clinical surveillance
 Advanced clinical development
 conclusion

4. Introduction
 Bio-pharmaceutics: the study of the chemical and physical properties of drugs and the biological
effects they produce.
 The task of discovering & developing safe & effective drug is gaining lots of importance these
days.
 Facts of drug discovery & development :
 1. Time :10-15 years
 2. Cost :800 millions-1 billions
 3. Drug tested :5000-10000 molecules
 4. Subject tested :1000-5000
 5. Drug approved :1

5. Introduction
 • Modern discovery is the product of cooperation
 • Both public & private organization play an unique roles in translating basic research into
medicine
 • Major biopharmaceutical companies are the primary source of R & D funding of new
medicines.
 The national institute of health (INH) provides leadership & funding stimulate basic research &
early stage development of technologies.

6. Importance of Biopharmaceutics in the
Overall Development Process
 Biopharmaceutics is an integral component of the overall development cycle of a drug
 Evaluation begins during the drug discovery process, proceeds through compound selection,
preclinical efficacy and safety testing, formulation development, clinical efficacy studies, and
post approval stages.
 At each stage, biopharmaceutical scientists interface with in multiple disciplines including
discovery chemistry and biology, drug safety assessment, clinical development, pharmaceutical
development, regulatory affairs, marketing, and manufacturing

7. Discovery and Preclinical Development:
 The preclinical development stage encompasses aspects of both drug discovery and drug
development.
 Discovery involves followings :
 1. Pre-discovery : Understanding the disease
 2. Target identification :choose molecules to target with a drug.
 3. Target validation : Test the target & confirm its roles in disease
 4. Drug discovery : find a promising lead compound that could becomes a drug.
 5. Early safety tests : perform initial tests on lead .
 6. Lead optimization : alter the structure of lead compound to improve properties .

8. Discovery and Preclinical Development:
 Successful drug must be :
 1. Absorption into the bloodstream
 2. Distribution to the proper site of action in the body.
 3. Metabolized efficiently & effectively
 4. Successfully excreted from the body
 5. Demonstrated to be not toxic.

9. Pre-clinical testing
 Scientists carry out in vitro & in vivo tests
 • They try to understand a drug’s kinetics toxicity & carcinogenicity.
 • The U.S Food & Drug Administration (FDA) requires extremely thorough testing before the
candidate drug can be studied in humans.
 The Application includes :
 1. The results of the pre clinical work
 2. The candidate drug‘s chemical structure &
 3. How it is thought to work in the body
 4. A listing of any side effects &
 5. Manufacturing information

10. Clinical trials
 Clinical trials comprise of three phases

11. Post-marketing Surveillance
 • Research on new medicines continues even after approval .
 • These studies are generally termed as phase 4 trials.
 • As a much larger no. of patients begin to use the drug , companies must continue to
monitor it carefully & submit periodic reports , including cases of adverse events ,to the FDA.

12. Advanced clinical development
 As a compound moves from Phase I into Phase II and eventually into Phase III, the objectives
of the clinical development program evolve from primarily safety and PK to safety and
efficacy.
 PK studies conducted in Phase I and II are used to establish a body of knowledge surrounding
the intrinsic properties of the medicinal agent (e.g., clear ance) as well as the dependency of
the performance on the actual product used.

13. Conclusions
 The discovery & development of new medicines is a long completed process.
 Research based pharmaceutical companies are committed to advancing science &
bringing new medicines to patients.
 Increased support from govt & organisation may helps in development safer &
cost effective medicines.

14. References
 FDA (U.S. Food and Drug Administration) Guidance Documents for Industry, 1995, Rockville.
Guidance for Industry. Immediate Release Solid Oral Dosage Forms. Scale-Up and
Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro Dissolution Testing,
and In Vivo Bioequivalence Documentation (November 1995);
 The Biopharmaceutics Classification System (BCS) Guidance (June 2005)
 Adessi, C. and Soto, C. (2002). Converting a peptide into a drug: strategies to improve
stability and bioavailability. Curr. Med. Chem. 9:963-978.
 Berridge, M. S., Lee, Z., and Heald, D. L. (2000). Regional distribution and kinetics of inhaled
pharmaceuticals. Curr. Pharm. Des. 6:1631-1651.