New Drug Development &CLINICAL TRIALS.pptx

includes the details of new drug development and different phases of clinical trials

1. NEW DRUG DEVELOPMENT & CLINICAL TRIALS

2. Overview Drug development Drug discovery Preclinical studies Clinical trials introduction phases of clinical trials

3. Drug Development 3 phases Drug Discovery Preclinical phase Clinical trial phase Molecule chosen acc to pharmacological prop Animal studies –PK, PD, toxicity studies Lead comp –efficacy safety, ADRs in human volunteers & pts

4. Drug Discovery

5. PRECLINICAL STUDIES Aim-To satisfy all the requirements that are needed before a test compound is considered fit to be tested for the first time in humans . Good laboratory practices-standardized procedure for the conduct of animal experiments Pharmacokinetics, pharmacodynamics tests Toxicity studies Special toxicity- effect on reproduction, teratogenicity, carcinogenicity, mutagenicity. Takes 2 years Rodents , Cat ,dog , monkeys

6. Clinical trials

7. CLINICAL TRIALS Systematic study of a new drug in human subjects to generate data for discovering or verifying the clinical claims or pharmacological and adverse effects with an aim to determine the safety and efficacy of the drug in question. 4 phases

8. Clinical trials Good Clinical Practice-(GCP)- guidelines by an International Conference on Harmonisation and Declaration of Helsinki of World Medical Association ICMR –national ethical guide lines for clinical trails in India . New drugs and clinical trials (NDCT) 2019 Institutional research committee, ethics committee. Informed consent Clinical trials – 4 phases

9. Clinical trials Good clinical practice guidelines includes Designing of trials Collection of data Recording of information Statistical analysis Documentation Reporting of results of clinical trials

10. Ethical considerations Ethics committee- as per Good Clinical Practice guidelines The Ethical principles Autonomy – Freedom , dignity and confidentiality of the subject. Beneficence -motive to do good to the subject or society Non maleficence –-not to do harm Justice -Observance of fairness, honesty and impartiality in obtaining, analyzing and communicating the data.

11. Phase 0 To reduce the cost and time of drug development process. Microdosing human study(1/100 of estimated human dose) Healthy volunteers To study pharmacokinectic pattern

12. Clinical trial Phase 1 : human pharmacology and safety Clinical pharmacological evaluation of new drug Clinical pharmacologist/trained physician Setting - all vitals monitored, resuscitative facilities available Healthy volunteers (20- 80) / pts To check for safety, tolerability, dangerous effects on vital functions. ADRs noted

13. Phase1 contd … PD effects in man Pharmacokinetics of drug in humans Safe clinical dose range in humans Predictable toxicity Non-blind or open label

14. Phase 11:Therapeutic exploration and dose ranging Trained physician 100-500 patients in 2-4 centres . Patient selection-Inclusion ,exclusion criteria Aim-Therapeutic efficacy, dose range Tolerability and pharmacokinetics Blinded or open label Randomization Drug dropped if not efficient

15. Phase 111: Therapeutic confirmation/ comparison Randomised double blind comparative trials 500- 3000 pts by several physicians at many centres . Designed to minimize error in information gathered in phase 1 and 2 Aim-value of drug in relation to existing therapy Safety , tolerability ,pharmacokinetic studies Indications finalized Guide lines for therapeutic use formulated New drug application submitted to licensing authority. NEW DRUG STATUS

16. Phase 1V- Postmarketing surveillance/studies Post licensing phase- field trials No fixed duration. Data collected from practicing physicians Performance of drug monitored for several years – rare side effects, unknown drug interactions, unknown therapeutic use . Effects on special groups studied Modified release dosage forms, additional routes of administration , fixed dose combinations Periodic safety update report submission

17. Drug development New drug design Purity ascertained Lead compd 1-2yrs Animal studies 2-4yrs

18. Drug development New compound Investigational new drug (IND) license 3-6 months Drug controller of india approval Institutional ethical committee Clinical trial ‘ Good Clinical Practice’ new drug clinical trials rules 2019 3-10yrs