Ten Keys For Drug Development

Mr. R M Gupta and Mr. S Vishweshwar

(Perfect Pharmaceutical Consultants Pvt. Ltd. Pune)

Kulkarni Sumant S.

(M. Pharm. (II) Student, J. S. S. College of Pharmacy Ooty)

Directive 1. “Write a clear SOP on drug development”.

Presenting a quality drug in the shortest development time is the goal of drug development. Start the project only after you have clear, concise drug development procedures and objectives. It shall be backed-up with cleaning, process and analytical validation.

Directive 2.”Run controlled pilot studies”

U

ncontrolled studies like non-validated assays generally give the wrong guidance. To evaluate a potential bioequivalent product with a fully validated analytical assay/ metabolite/impurity procedure a controlled pilot study often works out more cost effective. Never do uncontrolled studies!

Directive 3. “Write and Report Facts Faithfully”

A failed result highlights a wrong development route hence it is a positive endpoint. Faithful reporting of Failed results is a duty of Investigator. Avoid average results as it may give wrong picture about the out-of-spec-results.

Directive 4. “Remember the 5C’s of documentation”

Write Clear statements, aims, objectives, conclusions and results.

Concise – Prepare a report that is to the point ; its all that’s needed.

Compact, avoid any padding - period!

Write Controlled prospective protocols and procedures for studies or processes. It will produce well-controlled documents.

Certify & Check - review and audit every document produced. Documents that have passed a careful and thorough audit review process shall be Signed, dated and stamped.

Directive 5. “Be Open and Direct “

Never hide a bad study report or a poor result. Review your firm’s out-of-specification SOP and check that there are no organization omissions.

Directive 6. “Investigate all abnormalities”

Test results that are out-of-specification, the result may well be a sampling or technician error.

Directive 7.

“Make your Application really clear, concise and user friendly “
Well prepared and assembled print or electronic files and dossiers are equally important as that of Experimental Findings. Make the reports attractive, stimulating, and interesting to read and review.

A document can entice or repel a reader simply by its construction - it can also be made a scientific work-of-art.

Directive 8.

“Treat regulators like your key personnel treat you”
Listen to regulators - they may know regulations that you don’t. Listen to their concerns clearly - it’s in your product’s interest.

Work with regulators - or they will work against you and your product may not get to the market place on time.

Treat regulators with respect - as you would like to be treated.

Remember an agency never looses an argument - the product only suffers and gets delayed due to incomplete data or regulatory requirements.

Directive 9.

“Talk to the regulators regularly.”

Allow regulators to review protocols prior to starting the work. Get their opinion and express your concerns openly. Regulators like openness and honesty - and work well with polite, respectful and professional personnel.

Directive 10.

“Take a hard look at your cGMPs “
The absence of GMP compliance simply adulterates your drug development pipeline.

Always follow cGMP Guidelines.

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This Article is brought to you by Perfect Consultants (India) Regulatory Affairs, for more detailed information please visit our site at:

1) www.perfect-consultants.com

2) www.perfect-consultants.com/services.html

3) www.perfect-consultants.com/products.html

Or email us at

info@perfect-consultants.com , gupta1@vsnl.com